Reported trial results for Osteoarthritis
Every Osteoarthritis trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
113 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
-
NCT05579665 · results posted 22 May 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 45 people with knee osteoarthritis, split evenly into three groups of 15. One group received platelet-rich plasma (PRP) injections — a preparation made from the patient's own blood — another received a substance called MSC secretome (a liquid derived from stem cell cultures), and the third received hyaluronic acid (HA), a gel-like substance sometimes injected into joints. All 45 participants completed the trial with no drop-outs. The trial measured two things: self-reported pain using a simple 1–10 scale (called the Visual Analog Scale, or VAS), and a broader questionnaire about pain, joint stiffness, and physical function (called the WOMAC, scored 0–96, where higher numbers mean more difficulty). The reported data shows that at the start of the trial, all three groups had an average VAS pain score of 5 out of 10. By a later time point, the reported VAS scores were 1 out of 10 for both the PRP and MSC secretome groups, and 2 out of 10 for the hyaluronic acid group. For the WOMAC questionnaire, the reported starting scores were 79 for the PRP group, 46 for the MSC secretome group, and 45 for the hyaluronic acid group (on a scale of 0–96). The reported scores at a later time point were 29 for PRP, 5 for MSC secretome, and 24 for hyaluronic acid. It is worth noting that the data as submitted lists some time points more than once with identical figures, and no labels clearly identifying which time points these scores correspond to were included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04864392 · results posted 30 March 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04864392) enrolled 576 participants across five groups, all of whom had knee osteoarthritis. Four groups received different doses or schedules of an investigational injection called LNA043, and one group received a placebo (an inactive injection). The trial was primarily measuring whether LNA043 affected the thickness of cartilage — the cushioning tissue inside the knee joint — over about two years (104 weeks). It also measured participants' self-reported knee pain and physical function using a standard questionnaire called WOMAC, where lower scores indicate less pain and better function. The reported data shows that for the primary outcome — change in cartilage thickness in a specific part of the knee joint — all five groups showed a small reduction in cartilage thickness over the two years. The four LNA043 groups showed reductions ranging from approximately −0.257 mm to −0.303 mm, while the placebo group showed a reduction of approximately −0.267 mm. For the secondary outcomes measuring pain and physical function using the WOMAC questionnaire (scored 0–100, where lower is better), all groups also reported reductions in their scores at two years. Pain scores fell by between approximately 27.8 and 32.5 points in the LNA043 groups, compared with approximately 30.0 points in the placebo group. Similar patterns were reported for the function scale and other cartilage thickness measurements across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03737149 · results posted 23 March 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT03737149) looked at a digital care programme called Mymobility, used alongside an Apple Watch, for people recovering from knee or hip replacement surgery. The trial ran across three phases. The first phase was a small pilot study involving 143 knee and 63 hip patients. The second phase was a randomised controlled trial — meaning participants were randomly assigned to either the Mymobility with Apple Watch programme or standard physical therapy — with 210 knee and 174 hip patients in the Mymobility group, and 245 knee and 204 hip patients in the standard care group. A third observational phase enrolled a much larger group of 3,867 knee and 1,653 hip patients using the Mymobility programme. The main thing the randomised phase was set up to measure was how many people were readmitted to hospital within 30 days of their surgery. The reported data shows that in the randomised phase, hospital readmissions within 30 days occurred in 4 knee patients and 4 hip patients using Mymobility, compared with 7 knee patients and 1 hip patient in the standard care group. For knee patients, a joint health questionnaire (scored 0–100, where higher means better knee health) returned an average score of 70.0 in the Mymobility group and 73.7 in the standard care group. For hip patients, a similar questionnaire returned 81.8 in the Mymobility group and 83.5 in the standard care group. A general quality-of-life measure (scored up to 1.0, where higher means better self-reported health) showed scores of 0.8–0.9 across all groups. The reported data also shows that 5 knee patients in the Mymobility group and 10 in the standard care group needed a procedure called manipulation under anaesthesia (where a doctor gently moves the joint while the patient is asleep) within 90 days. A timed walking test — measuring how long it takes to stand up, walk a short distance, and sit back down — recorded average times of 9.3 seconds (Mymobility, knee), 10.9 seconds (Mymobility, hip), 10.2 seconds (standard care, knee), and 9.7 seconds (standard care, hip). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04886258 · results posted 28 January 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04886258) enrolled 115 people with knee problems — 58 received the investigational drug DFV890 and 57 received a placebo (an inactive dummy treatment). The trial was primarily measuring changes in knee pain using a standard questionnaire called the KOOS Pain Scale, where a score of 100 means no pain and 0 means extreme pain. It also tracked several secondary measures, including signs of joint inflammation seen on a specialised MRI scan, a blood marker of body-wide inflammation (hsCRP), white blood cell counts (neutrophils), and how the drug moved through the bloodstream. Of those who started, 52 in the DFV890 group and 54 in the placebo group completed the study. The reported data shows that, on the KOOS Pain Scale, participants in the DFV890 group had an average improvement (increase) of 21.7 points from their starting score, compared to an average improvement of 16.7 points in the placebo group. For the MRI inflammation marker (called Ktrans — a measure of how leaky blood vessels in the joint lining are), the DFV890 group showed an average change of −0.0029 min⁻¹ and the placebo group −0.0003 min⁻¹, both representing small reductions from baseline. The reported data shows that the blood inflammation marker hsCRP fell on average in the DFV890 group across time points (ranging from around −0.9 to −2.0 mg/L), while in the placebo group it showed little change or a small rise. Neutrophil counts (a type of infection-fighting white blood cell used to check whether the drug was having its intended biological effect) fell more in the DFV890 group (around −1.0 across time points) than in the placebo group (around −0.05 to −0.2). Blood-level measurements of DFV890 itself were also reported, with peak concentrations of 1,550 and 3,240 ng/mL recorded at two different time points, and related drug exposure figures also provided — these were measured in the DFV890 group only, as expected. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03299959 · results posted 5 December 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03299959) enrolled 251 people with knee cartilage damage. Participants were placed into one of two groups: 167 people received a device called Agili-C™ (an implant designed to support cartilage repair), and 84 people received what the trial called "Surgical Standard of Care" — meaning the usual surgical treatment a doctor would normally offer. The trial followed participants for up to 60 months (five years), and it measured changes in knee-related scores covering pain, quality of life, daily function, symptoms, and sports activity. By the end of the study, 130 people in the Agili-C™ group and 57 in the standard care group had completed the trial. The reported data shows that all scores were measured using a questionnaire called KOOS (Knee Injury and Osteoarthritis Outcome Score), where higher numbers mean a better reported outcome on a scale of 0 to 100. The numbers below represent the average change from each participant's starting score to their five-year score — so a larger number means a bigger reported improvement from where they started. For the Agili-C™ group versus the standard care group, the reported changes were: **pain** — 37.71 vs 18.68 points; **quality of life** — 45.22 vs 22.29 points; **daily function** — 33.03 vs 16.45 points; **symptoms** — 30.52 vs 15.52 points; and **sports activity** — 47.32 vs 25.11 points. The reported data also shows that the proportion of participants who recorded an improvement of 30 points or more in the overall combined KOOS score at five years — described in the trial as "responders" — was 74% (about 3 in 4) in the Agili-C™ group, compared with 34% (about 1 in 3) in the standard care group. These figures are based on a statistical modelling approach and represent averages across the group, not individual results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT05838742 · results posted 10 November 2025
According to the results reported on ClinicalTrials.gov, this trial tested an investigational medicine called GSK3858279 in people with knee pain from osteoarthritis (a condition where the cartilage in joints breaks down over time). A total of 314 people started the trial across five groups: one group received a placebo (an inactive dummy injection), and the other four groups received different doses or dosing schedules of GSK3858279. The main thing being measured was how much knee pain scores changed after 12 weeks, using an 11-point self-reported scale where 0 means no pain and 10 means the worst possible pain. The reported data shows that after 12 weeks, all five groups — including the placebo group — showed a reduction in their average daily knee pain scores. The placebo group's score dropped by 2.13 points on average, while the GSK3858279 groups dropped by 1.66 points (60 mg weekly), 1.88 points (240 mg every two weeks), 1.74 points (240 mg weekly), and 2.03 points (360 mg weekly). For the secondary measures — which included other knee pain questionnaires, a physical function questionnaire, and an overall disease rating — the reported data shows similarly modest reductions across all groups, with the placebo group's results generally in a similar range to the GSK3858279 groups. The reported data also shows that most participants across all groups did not complete the full trial period. Regarding tracked side effects and lab results, the reported data shows these were collected and recorded across all groups, though the full breakdown of all side effect categories was not completely reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT07112885 · results posted 22 September 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people with knee osteoarthritis, split evenly into two groups of 25. One group received a procedure called microfracture (where small holes are made in the bone to stimulate the joint) combined with an injection of stromal vascular fraction (SVF — a preparation of cells taken from a person's own fat tissue), while the other group received SVF alone. All 50 participants completed the trial. The trial was measuring changes in knee symptoms and cartilage appearance on MRI scans over time. The reported data shows that for the main symptom questionnaire (the WOMAC score, where a lower number means fewer symptoms, on a scale of 0–96), the Microfracture Plus SVF group started at around 49.5 and their scores dropped to around 33–34 at later time points. The SVF Only group started at around 50.6 and their scores remained closer to 47–50 across later time points. For the MRI-based cartilage scan score (WORMS, where a lower number means less cartilage damage, on a scale of 0–84), the Microfracture Plus SVF group recorded scores of approximately 41.3 at the start and 40.6 later, while the SVF Only group recorded approximately 68.8 at the start and 66.8 later — noting that the two groups appeared to start with quite different baseline scores on this measure. The reported data also shows results for two secondary measures. On the Lysholm Knee Function score (0–100, where higher is better), both groups started around 47 and both reached approximately 82 at later time points. On the pain scale (VAS, 0–10, where lower means less pain), the Microfracture Plus SVF group started at around 5.6 and dropped to approximately 2.8 at later time points, while the SVF Only group started at around 6.3 and recorded approximately 5.4–5.8 at later time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04748510 · results posted 8 August 2025
According to the results reported on ClinicalTrials.gov, this trial involved 100 people who were having a total knee replacement. They were split into two equal groups of 50: one group received a surgical technique called "functionally aligned" placement of the knee implant, and the other received a technique called "mechanically aligned" placement. The trial was measuring how each group's knee felt and moved two years after surgery compared to before it. A total of 48 people in the functionally aligned group and 44 in the mechanically aligned group completed the study. The reported data shows three main things were measured. First, a "Forgotten Joint Score" — a questionnaire (scored 0 to 100, where higher means better) that asks how often a person is aware of their knee in daily life — changed by an average of 50.1 points in the functionally aligned group and 46.4 points in the mechanically aligned group. Second, the "Oxford Knee Score" — another questionnaire (scored 0 to 48, where higher means better) about knee pain and function — changed by an average of 17.0 points in the functionally aligned group and 17.2 points in the mechanically aligned group. Third, the range of movement of the knee (how far it could bend and straighten, measured in degrees) changed by an average of 2.8 degrees in both groups. For the secondary outcomes — including limb alignment from X-rays, pain medication use, and knee stability — no numerical results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT05765435 · results posted 3 July 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled a very small number of participants — two people in each of three groups: a Control group, a group receiving Neuromuscular Electrical Stimulation (NMES, a technique that uses mild electrical impulses to activate muscles), and a group receiving both NMES and Functional Electrical Stimulation (FES, a related electrical stimulation approach). In total, six people started the trial, but one person from the NMES group and one from the NMES and FES group did not complete it. The trial was measuring changes in thigh muscle strength and perceived pain in people with, or at risk of, knee problems. The reported data shows that for thigh muscle strength — measured using a handheld device that records force in Newtons — the Control group recorded an average of around 76.6 Newtons at the start and 76.4 Newtons at the end, suggesting little change. The NMES group recorded around 70.2 Newtons at the start and 79.9 Newtons at the end. The NMES and FES group recorded around 148.5 Newtons at the start and 198.9 Newtons at the end. For perceived pain, scored on a 0–20 scale (where higher means more pain), the reported data shows the Control group changed by 0.5 points (start) and −2 points (end period), the NMES group by −1 and 0 points, and the NMES and FES group by 1 and 5 points. Several other planned measurements — including walking performance, physical function, muscle volume, and program adherence — were listed in the trial design but no results data was reported for those outcomes. It is worth noting that with only two participants per group and incomplete data for several outcomes, the reported numbers are extremely limited in scope. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04399928 · results posted 11 April 2025
According to the results reported on ClinicalTrials.gov, this trial followed 478 people who received a hip replacement component called the R3™ Acetabular System — a cup-shaped implant used in total hip replacement surgery. The trial set out to track how long the implant stayed in place without needing to be surgically revised (removed and replaced), and also to measure how participants felt about their hip function and activity levels over time, across check-in points up to 10 years after surgery. Of the 478 people who started, 350 completed the full study period. The reported data shows that, using a statistical method called Kaplan-Meier survival analysis (a way of estimating how many implants remained in place over time, accounting for people who left the study early), approximately 89% of implants had not required revision by the 10-year mark. For the patient-reported hip function score (called HOOS, rated 0–100 where higher is better), the reported average score before surgery was 37.8, rising to scores in the mid-to-high 80s across the follow-up visits, reaching 89.3 at 10 years. A second function score (modified Harris Hip Score, also 0–100, higher is better) showed a reported pre-surgery average of 51.5, climbing to scores in the low 90s from the 3-year point onwards. A physical activity rating (UCLA scale, 1–10, higher meaning more active) started at a reported average of 3.4 before surgery and rose to around 5.6–6.1 across the follow-up visits. The reported data also includes X-ray findings tracking bone changes around the implant (called atrophy — bone thinning — and hypertrophy — bone thickening). At the 1-year X-ray check, no hips showed atrophy around the cup portion of the implant, and this remained the case at later time points for the cup, though small numbers showed findings around the stem portion at some visits. Hypertrophy around the cup portion was reported in 4 hips at 1 year, rising to 63 hips by 10 years, while hypertrophy around the stem was reported in 32 hips at 3 years but only 1 at 5 years. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04168593 · results posted 27 March 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 120 people in total, split evenly across four groups of 30. The study was looking at knee osteoarthritis (a condition causing joint pain and stiffness) and compared four combinations of acupuncture and cupping therapy — some participants received real versions of one or both treatments, while others received "sham" (pretend) versions used as a comparison. By the end of the trial, between 26 and 29 people in each group had completed the study. The reported data shows two main pain measures were used. The first was the WOMAC Pain scale (scored 0–20, where higher means more pain). Scores at the end of the trial were reported as: 11.60 for the sham-only group, 11.30 for the real cupping plus sham acupuncture group, 10.80 for the real acupuncture plus sham cupping group, and 9.83 for the real acupuncture plus real cupping group. The second measure was a VAS pain score (a 0–100 scale where higher means more pain), with reported scores of 67.43, 61.57, 47.87, and 47.43 for the same four groups respectively. It is important to note that these appear to be end-of-study scores rather than changes from the start, and starting scores were not reported in the data provided. For the secondary outcome, the reported data shows that across all four groups combined, 72 out of 110 participants who completed the study were recorded as having reduced their use of pain-relief medications. Broken down by group, this was 12 participants in the sham-only group, 18 in the real cupping group, 19 in the real acupuncture group, and 23 in the combined real acupuncture and real cupping group. No further detail about the amount of reduction was reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04124042 · results posted 27 March 2025
According to the results reported on ClinicalTrials.gov, this trial tested an investigational injection called XT-150 for knee pain. The trial was run in two stages (Stage A and Stage B), with participants receiving either a lower dose of XT-150 (0.15 mg/mL), a higher dose (0.45 mg/mL), or a placebo (an inactive injection) in Stage A, and then one of the two XT-150 doses in Stage B. A total of 286 people started the trial across the six treatment groups, with between 39 and 43 people in each group completing the full study. The main things being measured were changes in knee pain scores using a standard questionnaire called WOMAC (where higher scores mean more pain), and the number of participants who experienced any unwanted health events during the study. The reported data shows that in Stage A, when looking at how many participants achieved at least a 30% improvement in their pain score by around Day 180, the numbers were 26 out of 96 in the lower-dose group, 28 out of 96 in the higher-dose group, and 38 out of 96 in the placebo group. The reported average change in pain score from the start of the study to Day 180 was minus 1.77 points for the lower dose, minus 1.95 for the higher dose, and minus 2.21 for the placebo group (on a scale of 0–20). By the end of the full study (around Day 360, after Stage B), the reported average change in pain score from the original starting point ranged from minus 2.9 to minus 3.87 points across the different dose combination groups. Changes in physical function scores (on a scale of 0–170) at the end of the study ranged from minus 8.66 to minus 13.63 across the groups. The reported data also shows that in Stage A, the number of participants who experienced any adverse events (unwanted health occurrences) was 66 in the lower-dose group, 41 in the higher-dose group, and 58 in the placebo group, with serious adverse events recorded for 4, 0, and 4 participants respectively. After Stage B, adverse event counts across the six combination groups ranged from 9 to 18 participants per group. No further breakdown of the nature of these events was included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04797897 · results posted 25 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04797897) compared two approaches to a type of partial knee replacement surgery called a unicompartmental knee arthroplasty (UKA) — one using a robotic-assisted system called CORI, and one using conventional (standard, non-robotic) surgical techniques. A total of four people took part, two in each group. However, only one person in each group completed the trial, with one person in each group not finishing. The main thing the trial was measuring was how well each approach achieved a target leg alignment after surgery, checked by X-ray at six weeks. The reported data shows that for the primary measure — leg alignment within three degrees of each person's individual target — one out of two participants in the CORI robotic group and one out of two participants in the conventional group met this goal at six weeks. Because only one person completed each group, these numbers represent a single individual on each side. For the secondary measures, which looked at the precise angles of the implanted knee components on X-ray, the reported data shows the following individual results: the femoral (thigh bone) front-view angle was 97 degrees in the CORI group and 95 degrees in the conventional group; the tibial (shin bone) front-view angle was 84 degrees versus 89 degrees; the combined front-view angle was 181 degrees versus 184 degrees; the side-view thigh bone angle was 0 degrees versus 5 degrees; and the side-view shin bone angle was 86 degrees versus 85.5 degrees. It is important to note that with only one completing participant in each group, the reported numbers reflect single individuals rather than a broader group, and no wider conclusions can be drawn from figures this small. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03889925 · results posted 24 February 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 64 people with knee problems — 32 in each of two groups. One group received a treatment called Autologous Conditioned Plasma (a preparation made from the patient's own blood), and the other received the same treatment combined with Hyaluronic Acid (a substance sometimes injected into joints). By the end of the study, 21 people in the first group and 22 in the second group had completed the trial, with 11 and 10 people respectively not finishing for reasons the data does not specify. The trial was measuring how participants rated their own knee pain, stiffness, and function using three standard questionnaires at multiple points in time. The reported data shows scores from three patient-reported questionnaires. On the WOMAC scale — where higher numbers mean worse pain, stiffness, and difficulty moving (possible total range roughly 0–96) — scores across the different time points ranged from about 21 to 27 in the plasma-only group, and about 22 to 29 in the combined group. On the IKDC knee function form — where higher scores (out of 100) mean better function — both groups scored in the low-to-mid 50s across most time points, with small fluctuations. On the KOOS score — also out of 100, where 100 means no symptoms — both groups recorded scores in the high 50s to mid 60s across the measured time points. The data does not report which time points these measurements correspond to, or whether the differences between groups were considered meaningful by the researchers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT05698368 · results posted 13 February 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05698368) enrolled 458 people in total across three groups: a Mindset Intervention Group (151 people), an Active Comparator Education Group (152 people), and a Survey-only Control Group (155 people). The trial was looking at whether a mindset-based program influenced several things in people with knee osteoarthritis, including knee pain, physical activity levels, attitudes toward physical activity, and how participants thought about their osteoarthritis (for example, whether they saw it as a catastrophe, something manageable, or an opportunity). By the end of the study, 130, 135, and 143 people completed the trial in each group respectively. The reported data shows the following changes from the start of the study to the end. For knee pain (rated 0–10, where lower is less pain), the Mindset Intervention Group reported a change of −0.5 points, the Education Group −0.2 points, and the Survey-only Group −0.1 points. For physical activity (scored 0–793, where higher means more activity), the reported changes were +38.9 for the Mindset Group, +32.6 for the Education Group, and +10.3 for the Survey-only Group. For attitudes toward physical activity (scored 1–4, where higher means viewing activity more positively), changes were +0.5, +0.3, and +0.1 respectively. Regarding how participants viewed their osteoarthritis, the "catastrophe" mindset score decreased by 1.1 points in the Mindset Group, 0.5 in the Education Group, and 0.2 in the Survey-only Group, while the "manageable" and "opportunity" mindset scores each increased by 1.1, 0.7, and 0.2 across those same groups. For osteoarthritis knowledge (scored 11–55), the Mindset Group reported a change of +10.5 points, the Education Group +3.1 points, and the Survey-only Group +0.6 points. Secondary measures of knee pain and physical function (shortMAC scale) also showed small reductions across all groups, with the Mindset Group reporting slightly larger changes than the others. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00753090 · results posted 30 January 2025
According to the results reported on ClinicalTrials.gov, this trial involved two groups of people who had received knee replacement implants. The trial group ("VG DDRP") started with 209 participants, and the control group ("VG CR") started with 117 participants — a total of 326 people across both groups. The trial was measuring knee function and pain using a standard scoring tool called the Knee Society Score (KSS), as well as looking at X-ray results and how many implants remained in place (unrevised) over time. It is worth noting that a large number of participants did not complete the study — 168 in the trial group and 96 in the control group — which the data does not fully explain. The reported data shows that, at the primary outcome time point, the trial group scored 89.7 out of 100 on the KSS Objective measure (covering pain and movement) and 89.9 out of 100 on the KSS Function measure (covering walking and stairs). The control group scored 91.8 on the Objective measure and 83.2 on the Function measure. According to the scoring system used, both groups' results fell in the "Excellent" range (80–100 points) at this point. Earlier time-point scores were also reported for both groups and showed a general upward trend from lower scores shortly after surgery toward higher scores over time, though the data does not specify which time points each set of numbers corresponds to. The reported data also shows results for X-ray measurements and implant survival. On a measure called the "total varus angle" (a way of assessing the alignment of the knee joint on X-ray), both groups recorded small angles across multiple time points, ranging roughly between 2 and 4 degrees. For radiolucency — the presence of faint lines visible on X-rays around the implant, which can be a sign of changes at the bone-implant boundary — varying numbers of participants showed these lines across different zones, with some differences between groups. Regarding implant survival at 10 years, the reported data shows 178 out of 209 participants in the trial group and 114 out of 117 in the control group had their implants still in place and unrevised at that point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03023410 · results posted 29 January 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03023410) was set up to look at the causes of early knee replacement revision surgery — that is, cases where a knee replacement needed to be redone not long after the original operation. The study aimed to compare two groups of patients: those who had a "partial revision" (where only some parts of the knee replacement were replaced) and those who had a "total revision" (where all components were replaced). It also planned to measure patients' knee function and general quality of life using two standard questionnaires. The reported data shows that only one participant was enrolled in the trial — placed in the Total Revision group — and that person did not complete the study. No participants were recorded in the Partial Revision group at all. Because of this, the reported data shows no numerical results for any of the outcome measures: no figures were submitted for the primary measure (causes of early revision), the Knee Society Score (a questionnaire about knee function and ability to walk and climb stairs), or the Veterans RAND 12-Item Health Survey (a questionnaire about general health and quality of life). In other words, the data for all outcomes was not reported, most likely because the trial was not able to enrol enough participants to generate any findings. This means no conclusions can be drawn from this trial about its research questions, as it effectively did not get off the ground. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05349500 · results posted 14 January 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people with osteoarthritis — 30 in a group receiving something called "OA CARE" and 30 receiving "Usual Care." By the end of the study, 23 people in the OA CARE group and 24 in the Usual Care group had completed it. The trial was measuring changes in participants' osteoarthritis symptoms — specifically pain, stiffness, and physical function — using a questionnaire called the WOMAC. On this questionnaire, scores range from 0 to 96, where a higher number means worse symptoms, and a lower (more negative) change score means symptoms were reported as improved compared to the start. The reported data shows that at the six-month mark, the OA CARE group's overall WOMAC score had dropped by an average of 7.8 points from where it started, while the Usual Care group's score had actually risen by 3.2 points (suggesting slightly worse symptoms on average). At 12 months, the OA CARE group's score had dropped by 8.3 points, compared to a drop of 3.3 points in the Usual Care group. For the pain-specific part of the questionnaire (scored 0–20), the reported data shows the OA CARE group's pain score dropped by 1.5 points at six months and 2.1 points at 12 months, while the Usual Care group showed a rise of 0.5 points at six months and a drop of just 0.4 points at 12 months. For the physical function part of the questionnaire (scored 0–68), the OA CARE group's score dropped by 4.9 points at six months and 4.5 points at 12 months, compared to a rise of 2.6 points and a drop of 2.6 points respectively in the Usual Care group. Stiffness subscale results were not reported separately in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04343716 · results posted 9 January 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04343716) enrolled 19 women with osteoarthritis — 3 White women and 16 Black women. The trial was measuring changes in knee pain and physical function over six weeks, comparing results between these two groups. Of the 19 who started, 16 completed the study (1 White woman and 15 Black women); 2 White women and 1 Black woman did not complete it. Two standard questionnaires were used to track pain: the WOMAC (a 0–20 pain scale, where higher numbers mean more pain) and the BPI (a 0–40 pain scale, where higher numbers also mean more pain). Change scores were calculated by subtracting the week-6 score from the starting score, so numbers further from zero suggest more change, while numbers closer to zero suggest little change. The reported data shows the following changes in pain scores after six weeks. For the WOMAC pain measure, White women recorded a change score of 1.0 and Black women recorded 0.76. For the BPI pain measure, White women recorded a change score of 4.5 and Black women recorded 1.15. On the secondary measures, WOMAC physical function change scores were 0.38 for White women and 0.82 for Black women, while BPI pain interference change scores were 2.55 and 1.68 respectively. Two additional pain tasks were also measured: after a repeated tapping task (Temporal Summation), White women's pain rating change was +10 and Black women's was −7.86; after a repeated chair-stand task, White women's change was 0 and Black women's was +6. Positive numbers in these last two measures were described as suggesting improved pain ratings, and negative numbers as suggesting worsening pain ratings. It is worth noting that the group sizes — particularly just 3 White women, with only 1 completing the study — are very small, which means the reported numbers should be interpreted with considerable caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT05986617 · results posted 17 December 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 30 in a group that used a wearable device (described as a band) and 30 in a control group who did not. The trial was looking at how long it took participants to reach the point where surgery was considered appropriate, as well as changes in body composition and surgical complication rates. The reported data shows that very few participants formally completed the study — only 1 person in the wearable device group and 5 in the control group were recorded as having completed it, with the remainder recorded as not completing the study. No explanation for this is included in the reported data. The reported data shows that, on average, participants in the wearable device group reached surgical indication (the point at which surgery was deemed suitable) in approximately 3.7 months, compared with approximately 8.7 months for the control group. Regarding body composition — meaning changes in body weight, fat, and muscle — the control group was reported to have lost more weight overall (around 37.1 lbs versus 16.2 lbs), more fat mass (around 28.4 lbs versus 11.4 lbs), and slightly more skeletal muscle mass (around 5.1 lbs versus 3.1 lbs) by the time they reached surgical indication. For surgical complications, the reported figure was zero participants with complications in both groups, though only those who reached surgical indication would have been included in this count. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03098563 · results posted 11 December 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 58 participants, each of whom took part in multiple experimental sessions. It was a crossover study, meaning each person received different combinations of treatments across those sessions — specifically: a placebo paired with another placebo (an inactive dummy substance), the opioid pain medicine hydromorphone paired with a placebo, the cannabinoid medicine dronabinol paired with a placebo, and hydromorphone combined with dronabinol. The trial was measuring whether any of these combinations changed participants' self-reported clinical pain ratings compared to where they started (their "baseline"), using a scale from 0 to 100 where a higher number means more pain. The reported data shows the largest shift in pain scores from baseline recorded during each session. For the placebo-only group, the reported scores were 24.19 and 12.76. For the hydromorphone plus placebo group, the figures were 30.48 and 9.40. For the dronabinol plus placebo group, the numbers were 28.55 and 12.80. And for the hydromorphone combined with dronabinol group, the reported values were 26.38 and 12.41. The data as submitted appears to include two sets of measurements per group, but no additional detail explaining what each set represents was included in the structured results, so that distinction cannot be clarified here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02154516 · results posted 6 December 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people in total — 20 in the investigational hip replacement device group and 6 in the control (standard comparison) device group. Of those, 16 and 4 participants respectively completed the study. The trial was measuring things like whether the hip implant needed to be surgically revised (replaced or adjusted), the levels of metal particles released into the bloodstream, patient-reported hip pain and function scores, and X-ray findings around the implant. The reported data shows that 1 participant in the investigational device group required a device-related revision, while none in the control group did. For metal ion levels in the blood — a measure of tiny metal particles that can be released from implants — the reported values were generally low across both groups throughout the study, mostly ranging from 0.1 to 0.3 nanograms per millilitre (ng/ml), though one reading in the control group reached 1.0 ng/ml at a particular time point. The Harris Hip Score (a 0–100 scale measuring pain and hip function, where higher is better) was only reported for the investigational group, starting at an average of 51.0 before surgery and rising to the mid-90s at several later follow-up points. Similarly, the Hip Disability and Osteoarthritis Outcome Score (another 0–100 patient questionnaire, higher being better) started at 44.9 and rose to the high 80s–low 90s over time for that same group. For X-ray findings, the reported data shows that radiolucent lines (faint lines visible on X-ray around the implant) were recorded in the investigational group at various time points, while none were recorded in the control group. Heterotopic ossification (unexpected bone growth around the joint) was also recorded in some participants in the investigational group at certain time points, but none in the control group. It is worth noting that this was a very small trial, and some data points were not broken down further in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05139030 · results posted 24 October 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 167 people in total — 85 in the EXPAREL admix group and 82 in the standard bupivacaine HCl group. The trial was looking at pain levels and painkiller use after surgery, comparing two types of local anaesthetic (pain-numbing) injections given at the time of the procedure. The main thing being measured was overall pain intensity across the first 96 hours (four days) after surgery, using a standard 0–10 pain scale, where 0 means no pain and 10 means the worst possible pain. The reported data shows that, for the primary measure — which combined all pain score readings over 96 hours into a single summary number (called an area under the curve, meaning a running total of pain scores over time, on a scale of 0 to 960) — the EXPAREL admix group recorded a score of 594.4, while the bupivacaine HCl group recorded 650.1. On the secondary measures, the reported data shows the EXPAREL admix group used an average of 109.19 mg of opioid (strong painkiller) medication over 96 hours, compared with 136.91 mg in the bupivacaine HCl group. The time until participants first took an opioid painkiller was reported as 4.15 hours in the EXPAREL admix group and 3.63 hours in the bupivacaine HCl group. Pain scores recorded at separate time points (0–24 hours, 24–48 hours, 48–72 hours, and 72–96 hours) were also reported for both worst and average pain, with values generally ranging from around 5.8 to 8.7 across both groups and all time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03524729 · results posted 19 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03524729) looked at people with ankle osteoarthritis and compared three different devices: an ankle-foot orthosis (AFO, a brace that supports the foot and lower leg), a rocker-bottom shoe (RB, a shoe with a curved sole), and a control condition (C, meaning no special device). Participants with ankle osteoarthritis tried all three conditions in different orders, so the study could compare how each one related to their daily activity and physical function. One healthy person without ankle osteoarthritis also took part as a comparison. In total, 11 people started the study and 9 completed it — 2 ankle osteoarthritis participants did not finish. The reported data shows that the main thing being measured was daily step count, tracked using a pedometer worn on the body. The numbers varied across participants and conditions. For example, one group of ankle osteoarthritis patients recorded step counts of around 3,453, 2,745, and 2,053 steps across their three different device periods. Another participant's results included counts as low as 503 steps and as high as 2,574 steps in different periods. The healthy control subject's step count data was not reported in the submitted results. For one of the secondary measures — a self-reported physical function score out of 100 (where a higher number means better function) — the reported data shows scores ranging roughly from 22.5 to 52 across participants and conditions. The reported data for several other secondary measures, including ankle joint movement, walking speed, and patient feedback about the devices, was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03969875 · results posted 7 May 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 90 people in total across three groups (31, 29, and 30 participants respectively), with 72 completing the study (24 in each group). The trial compared three different nerve-block approaches used to manage pain after shoulder surgery: a continuous catheter (a small tube that delivers ongoing local anaesthetic near a nerve in the neck), a single injection of a standard local anaesthetic combined with a steroid (dexamethasone), and a single injection of a longer-acting form of local anaesthetic (liposomal bupivacaine). The main thing being measured was participants' pain levels, rated on a 0–10 scale where 0 means no pain and 10 means the worst possible pain. The reported data shows that pain scores — measured at multiple time points — varied across the groups. At the earliest time points all three groups reported a score of 0.00. At a later time point, the catheter group and the bupivacaine-with-steroid group both scored 0.00, while the liposomal bupivacaine group scored 2.00. At subsequent time points, scores rose to 2.00, 5.50, and 0.50 respectively, and then 2.50, 3.00, and 2.00 in the final measurement. For the secondary outcomes, the reported data shows that the time before participants first asked for additional pain relief was 1.5 hours for the catheter group, 3.5 hours for the steroid injection group, and 2.19 hours for the liposomal bupivacaine group. The total pain-relief medication used during the hospital stay (measured in morphine-equivalent units) was reported as 30.00 for the catheter group, 21.05 for the steroid injection group, and 13.25 for the liposomal bupivacaine group. The duration of pain-free time on day one was reported as 6 hours, 11 hours, and 8 hours respectively. Arm weakness and arm numbness scores were also tracked across multiple time points and were broadly similar across groups, with scores gradually increasing over time on both scales. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03005873 · results posted 22 April 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03005873) involved 76 people in total, split across three groups: a lower-dose TLC599 group (26 people), a higher-dose TLC599 group (24 people), and a placebo group (26 people). The trial was measuring changes in knee pain related to osteoarthritis over 12 weeks, using a standard questionnaire called the WOMAC Pain subscale. This questionnaire asks five questions about pain, and the answers are combined into a score ranging from 0 to 4, where a higher number means more pain and a lower number means less pain. Not everyone finished the study — 25, 21, and 22 people completed it in the lower-dose, higher-dose, and placebo groups respectively. The reported data shows how much each group's average pain score changed from the start of the study to week 12. A negative number means the average score went down (i.e., participants reported less pain on the questionnaire). The lower-dose TLC599 group had an average change of −0.83 points, the higher-dose TLC599 group had an average change of −0.64 points, and the placebo group had an average change of −0.47 points. The reported data does not include additional statistical detail — such as whether the differences between groups were considered meaningful by conventional measures — so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01063751 · results posted 16 January 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 275 people who received a hip replacement using a device called the Tritanium® Primary Acetabular Shell — a cup-shaped implant placed in the pelvis as part of a total hip replacement. The main thing the trial was measuring was how many of those implants needed to be surgically revised (removed or replaced) within five years. The trial also tracked participants' self-reported quality of life, pain, physical function, and activity levels using several standard questionnaires. Of the 275 people who started, 41 were recorded as having completed the study, while 234 did not complete it; the reasons for non-completion were not detailed in the reported data. The reported data shows that 6 hips (out of those assessed) underwent revision of the acetabular shell during the study period. For screw usage — screws are sometimes used to help hold the cup in place — the data shows figures of 178 and 63 hips recorded across two categories, though the breakdown between those categories was not clearly labelled in the submitted data. The Harris Hip Score, a 0–100 measure of hip pain and function (higher is better), was reported at approximately 90 points across three time points. The SF-12 general health questionnaire reported physical scores in the mid-to-high 40s and mental scores in the mid-50s across multiple time points (out of 100, where higher means better health). Activity level scores (on a scale of 1–18) ranged from around 10.7 to 11.6, and quality-of-life scores from the EQ-5D questionnaire showed visual scale scores in the high 70s to low 80s (out of 100) and index scores around 0.84–0.88 (out of 1.0) at various follow-up points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04612036 · results posted 29 November 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04612036) enrolled 60 people in total who had received one of three types of knee replacement implants: 25 received the Journey II Bi-Cruciate Stabilized (BCS), 25 received the Journey II Cruciate Retaining (CR), and 10 received the Journey II Bi-Cruciate Retaining (BCR). All 60 participants completed the study. The trial was measuring how the bones in the replaced knee actually moved during a deep knee bend — specifically, how far the thigh bone shifted forward or backward over the shin bone, how much the knee rotated, and how deeply participants could bend their knee while bearing weight. The reported data shows the following averages across the three implant groups. For backward sliding of the inner (medial) side of the thigh bone during a deep knee bend, the figures were 6.9 mm for the BCS group, 0.2 mm for the CR group, and 4.4 mm for the BCR group (negative values meaning the bone rolled backward, which is considered the natural direction). On the outer (lateral) side, the backward sliding measured 12.5 mm, 4.7 mm, and 9.4 mm respectively. For the twisting (rotation) of the knee joint during bending, the reported averages were 7.1 degrees, 5.6 degrees, and 6.0 degrees across the three groups. The maximum knee bend achieved while bearing weight averaged 108 degrees for the BCS group, 121 degrees for the CR group, and 105 degrees for the BCR group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04627038 · results posted 2 November 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 202 people in total — 135 in the group receiving a 600 mg dose of the investigational medicine LY3556050, and 67 in the group receiving a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in pain and physical function in people with osteoarthritis, using several questionnaires and rating scales completed by participants themselves. Of those who started, 81 people in the LY3556050 group and 53 in the placebo group completed the study. The reported data shows that for the main (primary) outcome — average pain intensity rated on a 0–10 scale where higher numbers mean worse pain — both groups reported a decrease from their starting scores. The LY3556050 group reported an average decrease of 1.67 points, while the placebo group reported an average decrease of 1.76 points. For the secondary outcomes, the reported data shows similar patterns: on the WOMAC pain subscale (0–20, higher = worse), scores fell by 2.57 in the LY3556050 group and 3.51 in the placebo group; on the stiffness subscale (0–8), by 1.15 and 1.39 respectively; and on the physical function subscale (0–68), by 8.33 and 12.18 respectively. For worst pain in the past 24 hours (0–10 scale), the LY3556050 group reported a decrease of 1.74 points compared with 2.05 in the placebo group. On the Patient's Global Impression of Change scale (1–7, where 1 = very much better), both groups reported scores of approximately 2.76 and 2.86 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT05080660 · results posted 6 September 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 160 people in total — 107 received a drug called LY3526318 (at a dose of 250 mg) and 53 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in pain and joint symptoms, primarily in people with osteoarthritis. The main thing being tracked was how participants rated their average pain over the previous 24 hours using a numbered scale from 0 (no pain) to 10 (the worst pain imaginable). By the end of the study, 94 people in the LY3526318 group and 51 in the placebo group had completed the trial. The reported data shows that, for the primary outcome — average daily pain score — both groups reported lower scores compared to where they started. The LY3526318 group's score decreased by an average of 0.95 points, while the placebo group's score decreased by an average of 1.18 points (on the 0–10 scale). For secondary pain measures taken at a later time point, the reported data shows decreases of 1.26 points for LY3526318 and 1.45 points for placebo. A separate joint pain questionnaire (called the WOMAC, scored 0–20 for pain) also showed decreases in both groups across two time points — ranging from about 1.87 to 2.51 for LY3526318, and 2.50 to 2.85 for placebo. Stiffness scores (measured on a 0–8 scale) similarly decreased in both groups, with reported changes ranging from around 1.04 to 1.16 for LY3526318 and 1.11 to 1.26 for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03818737 · results posted 27 July 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 475 people with knee osteoarthritis across four groups. Three groups received different types of stem cell injections — sourced from bone marrow, body fat (adipose tissue), or umbilical cord tissue — while a fourth group received a corticosteroid (anti-inflammatory) injection for comparison. The trial was measuring changes in knee pain and overall knee health over time, using several questionnaires and MRI scans. The reported data shows changes in pain scores across all four groups at multiple follow-up time points. On a pain scale of 0–100 (where higher numbers mean more pain), the reported reductions from starting levels ranged roughly from about 16 to 29 points across all groups and time points — with negative numbers meaning pain had gone down since the start of the trial. On a separate knee health questionnaire (KOOS), where higher scores mean fewer symptoms, all four groups showed positive changes from their starting scores, ranging from roughly 12 to 19 points across time points. A broader quality-of-life score (EQ-5D-3L, rated 0 to 1) showed a reported change of 0.1 across all groups at all time points. MRI scans measuring the severity of osteoarthritis in the knee (scored 0–69, higher meaning worse) showed scores that remained broadly similar across time points within each group, ranging from approximately 37.6 to 40.8 depending on the group and time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04490395 · results posted 5 January 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 39 people in total — 19 in a programme called "Engage PA" (a structured physical activity support programme) and 20 in a comparison group called "Treatment as Usual Plus Fitness Tracker" (standard care with a wearable activity tracker). Almost all participants finished the study: all 19 in the Engage PA group and 19 of the 20 in the comparison group completed it. The trial was primarily looking at whether enough people could be recruited and would stay in the study, and how satisfied Engage PA participants were with the programme — suggesting this was an early-stage feasibility trial rather than a large definitive study. The reported data shows that, on the satisfaction measure, 89% of Engage PA participants said they were "mostly" or "very" satisfied with the programme. For the secondary measures, the trial used a questionnaire (scored 5–25, where higher numbers mean worse outcomes) to track arthritis-related pain, physical functioning, and psychological wellbeing at the start and end of the study. The reported data shows that the Engage PA group's pain/symptom score went from 13.72 at the start to 11.78 at the end, while the comparison group's score went from 14.90 to 14.58. Physical functioning scores were 6.38 (start) and 6.64 (end) for Engage PA, and 7.44 (start) and 7.51 (end) for the comparison group. Psychological distress scores were 10.36 (start) and 10.59 (end) for Engage PA, and 10.37 (start) and 10.33 (end) for the comparison group. No further statistical analysis of these differences was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02556710 · results posted 8 August 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT02556710) enrolled 480 adults with knee pain — 237 received a 4 mL injection of AMPION™ (the treatment being studied) and 243 received a 4 mL saline (salt water) placebo injection. The trial was measuring changes in knee pain and knee function over 12 weeks, using a standard questionnaire called the WOMAC scale, where scores range from 0 (no problem) to 4 (extreme problem). A lower score after treatment means less pain or better function compared to the start. The reported data shows that, for the main outcome — change in knee pain — participants in the AMPION™ group had an average score change of −0.91, while those in the placebo group had an average change of −0.89. In other words, both groups reported a similar reduction in their pain scores over the 12 weeks. For the secondary outcome of knee function, the reported data shows an average score change of −1.04 in the AMPION™ group and −0.97 in the placebo group — again, both groups showed a comparable change. The trial also reported a separate, after-the-fact analysis looking at a subgroup of participants with more advanced knee disease (called Kellgren-Lawrence Grade IV); in that subgroup, the AMPION™ group had a pain score change of −0.81 compared to −0.62 in the placebo group, though this analysis was not part of the original plan. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03182686 · results posted 8 August 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03182686) looked at a treatment called Ampion compared to a saline (saltwater) injection for people with knee osteoarthritis. A total of 168 people took part — 144 received a 4 mL injection of Ampion and 24 received a 4 mL saline injection. Of those, 137 people in the Ampion group and all 24 in the saline group completed the study. The trial's main goal was to measure how many participants in each group could be classified as a "responder" — meaning they met certain pre-set thresholds for improvement in knee pain, physical function, and their own overall assessment of how they felt. The reported data shows that, using the study's pre-defined responder criteria, 102 out of 144 participants (roughly 71%) in the Ampion group were classified as responders. In the saline group, 15 out of 24 participants (roughly 63%) were classified as responders. No secondary outcome measure data was included in the structured results submitted to ClinicalTrials.gov, so further detail on other measurements was not reported there. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01891396 · results posted 12 May 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 368 people with knee osteoarthritis across three groups: 149 received an injection of a combination product containing hyaluronic acid and a corticosteroid (called Cingal®), 150 received hyaluronic acid alone (called Monovisc®), and 69 received a saline (salt water) injection as a comparison. The vast majority completed the trial — 145, 145, and 66 people respectively. The trial was mainly measuring changes in knee pain using a standard questionnaire called the WOMAC Pain Score, where 0 means no pain and 100 means the worst possible pain, with a larger drop from the starting score meaning more reported pain reduction. The reported data shows that at 12 weeks, the average WOMAC pain score had dropped by 40.2 points in the Cingal® group, 36.1 points in the Monovisc® group, and 31.0 points in the saline group — all measured from each group's starting score. At earlier time points, the Cingal® group's average pain score had dropped by 34.6 points at 1 week and 40.1 points at 3 weeks, compared to 29.6 points and 34.9 points respectively in the Monovisc® group. A separate measure — the "responder rate" at 12 weeks, which counts the share of participants who met a defined threshold for meaningful improvement — was reported as 92.0% in the Cingal® group and 81.9% in the saline group. On a separate question asking patients how much their knee was bothering them overall (scored 0–100), the average score dropped by 36.5 points in the Cingal® group and 25.3 points in the saline group at 12 weeks; at 1 week it dropped by 32.8 points in the Cingal® group and 24.7 points in the Monovisc® group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04084288 · results posted 5 May 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04084288) enrolled 41 adults who were having a total knee replacement surgery. All 41 participants completed the study — none dropped out. The trial involved a single group who received postoperative acupuncture, and it was primarily looking at how many patients were able to stick to a low-dose opioid (painkiller) plan in the 30 days after their surgery. A "low-dose" plan was defined as taking 15 or fewer tablets of 5mg oxycodone (or the equivalent amount of another opioid painkiller) over that period. The reported data shows that 26 out of 41 participants stayed within that low-dose opioid limit over the 30 days following surgery. For total opioid use measured at different points in time, the reported figures (in standardised painkiller units called oral morphine equivalents) were 14.9, 11.9, 7.3, 13.5, 108.3, and 0 — though the specific time points these figures each correspond to were not clearly labelled in the submitted data. Pain scores were recorded on a 0–10 scale (where 0 means no pain and 10 means the worst pain imaginable), and the reported values at various time points were 5.1, 4.2, 3.7, 3.7, 3.0, and 2.4. The reported data also shows that only 1 participant needed a different oral pain medication than prescribed, and none required additional rescue medications by day 30. Regarding side effects such as nausea, vomiting, itching, and constipation, the numbers of participants experiencing these were recorded both in the recovery room and on the first day after surgery, with figures ranging from 0 to 11 participants depending on the specific side effect and time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03429049 · results posted 8 April 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03429049) enrolled 332 people in total — 138 in the placebo group and 194 in the CNTX-4975-05 group. Of those, 136 and 189 respectively actually received their assigned treatment, and 110 and 152 completed the study. The trial was measuring knee pain related to osteoarthritis, specifically looking at how scores on several self-reported questionnaires changed from the start of the trial to the end. The main thing being measured was participants' average pain in the affected knee while walking, rated on a scale of 0 (no pain) to 10 (worst possible pain). The reported data shows that, for the primary measure — walking pain scored on the 0–10 scale — the placebo group's average score dropped by 2.84 points from their starting score, while the CNTX-4975-05 group's average score dropped by 3.17 points. For the secondary measures, participants also completed a widely used arthritis questionnaire called the WOMAC, which covers pain, stiffness, and physical function separately. On the pain section (scored 0–50), the placebo group's score fell by an average of 12.72 points and the CNTX-4975-05 group's fell by 15.42 points. On the stiffness section (scored 0–20), the drops were 5.21 points for placebo and 6.15 points for CNTX-4975-05. On the physical function section (scored 0–170), the reported drops were 42.70 points for placebo and 50.49 points for CNTX-4975-05. In all cases, a lower score indicates a better outcome on these scales. It is worth noting that both groups — including the placebo group — reported reductions across all measured scores, which is a common pattern in clinical trials. The reported data shows the numbers as submitted, but does not on its own tell us whether the differences between the two groups are considered meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03661996 · results posted 9 March 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03661996) enrolled 854 people across five groups, each testing a different way of administering an injection called CNTX-4975-05 into the knee — a treatment being studied for knee osteoarthritis pain. The five approaches varied in how the knee was cooled or numbed before the injection, including different cooling devices, gel packs, and local anaesthetic. The main goal was to find out which preparation method scored best on a combined measure of three things: how much pain participants felt during the procedure, how satisfied participants were with the process, and how satisfied the treating clinician was. Secondary measurements looked at how participants' self-reported knee symptoms, pain, and function changed from the start of the trial to eight weeks later, using a standard knee questionnaire called the KOOS (a scoring tool where higher numbers suggest fewer problems). The reported data shows that on the primary combined score — which ran from 3 (worst) to 21 (best) — the five groups scored as follows: the standard cooling device group scored 17.18, the gel pack cooling group scored 18.26, the shortened gel pack cooling group scored 16.48, the single-needle injection with 2% local anaesthetic group scored 17.40, and the single-needle injection with 1% local anaesthetic group scored 16.00. For the secondary KOOS measures at eight weeks, the reported data shows changes from baseline across the different participant types. On the pain subscale, changes ranged from approximately 22 to 26 points across groups. On the symptoms subscale, changes ranged from roughly 17 to 20 points. Changes in daily function scores ranged from about 21 to 26 points, sports and recreational activity scores changed by roughly 25 to 33 points, and the single walking pain question showed changes of around 21 to 26 points. These figures represent the average change from the starting score to week eight, where a positive number means scores moved in the direction of fewer reported problems. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03586687 · results posted 2 March 2022
According to the results reported on ClinicalTrials.gov, this trial involved 19 people in total, split across three groups: 6 people received a low dose (20 mg) of a steroid called triamcinolone mixed with a local anaesthetic, 9 people received a medium dose (40 mg), and 4 people received a high dose (80 mg). The trial was measuring shoulder pain and disability over time using a questionnaire called the SPADI (Shoulder Pain and Disability Index), where scores run from 0 to 100 and a higher score means more pain and difficulty. It also tracked any reactions to the steroid injection and whether any participants went on to have shoulder replacement surgery. The reported data shows that SPADI scores were recorded at the start of the trial and then again at 2, 4, and 6 months. At the start, average scores were around 58 for the low-dose group, 61 for the medium-dose group, and 45 for the high-dose group. At 2 months, the reported scores were approximately 31, 49, and 22 respectively. At 4 months they were around 45, 51, and 36, and at 6 months approximately 45, 58, and 26. Regarding reactions to the steroid, the reported data shows 1 reaction in the low-dose group and 2 in the medium-dose group at the first time point, with none reported at later time points across all groups. As a secondary measure, 3 participants from the low-dose group, 1 from the medium-dose group, and 1 from the high-dose group went on to have shoulder replacement surgery. SPADI scores at one year for those who had surgery were reported as 2, 12, and 4 for the three groups respectively, though given the very small numbers involved in these subgroups, the data was not reported at the individual participant level. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04103515 · results posted 12 October 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people in total — 25 who received one type of knee replacement implant called a PCR (posterior cruciate-retaining) TKA, and 25 who received another type called a PS (posterior-stabilised) TKA. TKA stands for total knee arthroplasty, which is a full knee replacement. All 50 participants completed the study. The trial was measuring how the bones in the replaced knee actually moved during two everyday activities — stepping up a step and doing a deep knee bend. Specifically, it tracked the movement of two parts of the thigh bone (the femur) where it meets the knee: the inner side (medial condyle) and the outer side (lateral condyle). The reported data shows movement measured in millimetres (mm), where a positive number means the thigh bone moved forward and a negative number means it rolled backward. During the step-up activity, the reported data shows the outer part of the thigh bone moved forward by 1.15 mm in the PCR group and 2.28 mm in the PS group. The inner part moved backward slightly in the PCR group (−0.36 mm) and forward slightly in the PS group (0.16 mm). During the deep knee bend, the reported data shows the outer part of the thigh bone moved backward by 1.52 mm in the PCR group and by a larger amount — 6.80 mm — in the PS group. The inner part moved forward by a very small amount in the PCR group (0.13 mm) and backward by 4.25 mm in the PS group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03275246 · results posted 6 October 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 8 people who underwent total knee replacement (knee arthroplasty) surgery using a device called the X-PSI Knee System. The trial was measuring whether this system could achieve accurate leg alignment after surgery, and also looked at cost-related timing factors and how patients felt about their pain and quality of life over time. Of the 8 people who started, only 2 completed the trial, and 6 did not complete it. No reason for non-completion was reported in the data. The reported data shows that no results were recorded for the two main things the trial set out to measure — leg alignment accuracy and cost-effectiveness timing — meaning those figures were not reported on ClinicalTrials.gov. For the additional patient-reported measures, results appear to have been collected at three separate time points (likely before surgery and at follow-up visits, though the exact timing was not specified in the data). Pain scores on a 0–10 scale (where 10 is the worst pain imaginable) were reported as 8.2, then 3.7, then 1.1 across the three time points. A knee function and pain questionnaire called the Oxford Knee Score (scored 0–48, where 48 is the best outcome) returned scores of 18.3, then 30.3, then 45.0. A general health self-rating scale (scored 0–100, where 100 is the best imaginable health) returned scores of 73.3, then 63.3, then 91.5. The reported data also includes responses across five health areas (such as mobility and pain), with small numbers of participants — ranging from 0 to 3 — recorded at different problem levels for each area, though the breakdown across time points was not clearly separated in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02723929 · results posted 17 August 2021
According to the results reported on ClinicalTrials.gov, this trial looked at whether a combination of two non-invasive brain stimulation techniques — mild electrical stimulation of the brain (transcranial direct current stimulation) and ultrasound applied to the head — could reduce knee pain in people with osteoarthritis, compared with a "sham" (dummy/inactive) version of the same treatments. A total of 64 people joined the trial: 30 in the active treatment group and 34 in the sham group. By the end of the study, 24 people in each group had completed it, with 6 and 10 people respectively not finishing. The reported data shows that pain was measured using a scale from 0 (no pain) to 10 (worst imaginable pain), and the numbers below represent how much the score changed from the start — a negative number means the score went down (i.e., lower reported pain). At the end of the full course of treatment, the active group's average pain score fell by 2.21 points, while the sham group's fell by 1.6 points. A separate follow-up pain measurement showed a change of −2.91 for the active group and −1.28 for the sham group. The reported data also shows that the average daily painkiller use (measured in paracetamol/acetaminophen equivalents) was 390.7 mg in the active group compared with 1,116.4 mg in the sham group. For balance (single-leg standing), the active group showed a 17.5% improvement from their starting point versus 3.0% in the sham group. In a step test (how many times participants could step up and back in 15 seconds), the active group improved by 27.0% and the sham group by 18.7%. A measure of the body's own internal pain-control pathway showed a 12% change in the active group versus 4.0% in the sham group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02650284 · results posted 4 June 2021
According to the results reported on ClinicalTrials.gov, this trial compared two types of knee replacement surgery — a bicompartmental knee replacement (BKR, which replaces two parts of the knee joint) and a total knee replacement (TKR, which replaces the whole joint). Eight people were enrolled in the BKR group and nine in the TKR group, though only five in each group completed the study. The trial measured knee function, pain, and quality of life using several standard questionnaires, collected at multiple points over time. The reported data shows the following for the main outcome — the Oxford Knee Score, a 12-question survey scored from 0 (poor) to 48 (better joint function and less pain): at the final reported time point, the BKR group averaged 41.2 and the TKR group averaged 43.75. For quality of life (EQ-5D, scored 0–1 with 1 being "full health"), the reported figures at the last time point were 0.48 for BKR and 0.65 for TKR. For self-rated pain on a 0–100 scale (where 0 means no pain), the BKR group reported scores of around 10–14 and the TKR group around 19–24 at later time points. On the Forgotten Joint Score — which measures how often people are aware of their artificial joint in daily life, out of 100, higher being better — both groups reached scores in the mid-to-high 60s by the final time point. The reported data also shows that zero participants in either group experienced loosening, reoperation, or revision during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03909178 · results posted 18 May 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03909178) enrolled 110 people with hip problems — 57 in a group that received hip arthroscopy surgery followed by physical therapy, and 53 in a group that received physical therapy alone. The trial was measuring how much participants' self-reported hip function and pain changed over time, using several standard questionnaires where higher scores generally mean better hip function. Most participants completed the study: 54 in the surgery-plus-physio group and 49 in the physio-alone group. The reported data shows changes in scores across multiple questionnaires at what appear to be three follow-up time points. For the primary measure — the modified Harris Hip Score (out of 100, where higher is better) — the surgery-plus-physio group reported average score improvements of 9.26, 12.63, and 17.32 points at the three time points, while the physio-alone group reported improvements of 4.42, 6.98, and 12.63 points. The trial noted that a change of around 6.9 points is considered a meaningful difference on this scale. For the secondary questionnaires, the reported data shows a similar pattern across all measures — including the Hip Outcome Score, Non-Arthritic Hip Score, International Hip Outcome Tool, Lower Extremity Functional Scale, and a pain scale (rated 0–10, where lower means less pain) — with the surgery-plus-physio group generally reporting larger average score changes at each time point compared with the physio-alone group. The exact time points for each set of measurements were not specified in the submitted data. It is important to note that these figures represent average changes across groups of participants, and individual results within the trial varied. No specific information about side effects or harms was included in the structured results data submitted to ClinicalTrials.gov, so that data was not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00994890 · results posted 13 May 2021
According to the results reported on ClinicalTrials.gov, this trial looked at three different doses of a drug called tanezumab (2.5 mg, 5 mg, and 10 mg). A total of 679 people were enrolled across the three groups — 231 in the lowest dose group, 222 in the middle dose group, and 226 in the highest dose group. The trial's primary focus was on monitoring participants' safety and health, including tracking any unwanted medical events (called adverse events), changes in blood and urine test results, heart trace (ECG) readings, and changes in a nerve health score called the Neuropathy Impairment Score (NIS), which measures things like muscle strength, reflexes, and sensation on a scale from 0 to 244, where a higher number means more impairment. It is worth noting that the data shows zero participants were recorded as having "completed" the study, which may reflect how completion was defined in this particular trial, rather than meaning everyone dropped out. The reported data shows that when it came to unwanted medical events, 158 people in the 2.5 mg group, 169 in the 5 mg group, and 181 in the 10 mg group experienced at least one such event. Serious adverse events were reported in 17, 12, and 20 participants across the three groups respectively. Abnormal blood or urine test results were recorded for 136, 121, and 130 participants. Very few participants had abnormal heart trace findings reported as adverse events — the numbers were 0 or 1 across the groups depending on the specific measurement. For the nerve health score (NIS), the reported data shows small changes from the starting scores at weeks 2, 4, and 8. For example, at week 2, the average change from baseline was −0.43 for the 2.5 mg group, −0.36 for the 5 mg group, and −0.23 for the 10 mg group (a negative number meaning a slight decrease in the score). Similar small changes — mostly in the range of around −0.1 to −0.4 — were reported at weeks 4 and 8 across all three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01763684 · results posted 23 April 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT01763684) involved 133 people in each of two groups — one group had knee surgery using "Signature Custom Guides" (personalised, patient-specific surgical guides), and the other had surgery using standard ("conventional") instruments. The trial was measuring how accurately the surgical components were positioned in the knee, as well as several other things including blood loss during surgery, how many instrument trays were needed, and knee function scores after surgery. The reported data shows that for the main outcome — the percentage of knees where all the surgical angles landed within 5 degrees of the intended target — 45% of knees in the custom guides group met this goal, compared with 29% in the conventional instruments group. For the secondary outcomes, the average difference between the intended and actual positioning of the thigh-bone component (measured by CT scan just after surgery) was reported as 3.55 degrees for the custom guides group and 4.75 degrees for the conventional group. Blood loss during surgery was reported as an average of 81.9 ml in the custom guides group and 54.8 ml in the conventional group. The number of instrument trays used averaged 4.2 for custom guides and 3.8 for conventional instruments. Knee function was measured using a standard questionnaire scored from 0 to 100 (higher meaning better); the reported data shows an "objective" score of 93.3 (custom guides) versus 95.0 (conventional), and a "functional" score of 88.1 (custom guides) versus 91.8 (conventional). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01295580 · results posted 9 April 2021
According to the results reported on ClinicalTrials.gov, this trial compared two knee injection treatments — ARTZ and DUROLANE — in people with knee osteoarthritis. A total of 174 people were assigned to the ARTZ group and 175 to the DUROLANE group, making 349 participants in all. Of those, 164 in the ARTZ group and 167 in the DUROLANE group completed the trial. The trial measured changes in knee pain, physical function, and how participants rated their overall condition, using a standard questionnaire called the WOMAC (Western Ontario and McMaster Osteoarthritis Index) as well as a self-assessment question about general wellbeing. The reported data shows the following changes from the starting point (where a negative number on the pain and function scores means a lower score than at the start, and a positive number on the wellbeing question means a higher score than at the start). For the primary pain measure, the ARTZ group showed an average change of −5.87 points and the DUROLANE group −5.97 points, on a scale of 0–20. For physical function (scale 0–68), the reported changes were −12.10 for ARTZ and −12.75 for DUROLANE in one measurement period, and −12.58 and −13.16 respectively in another. For the overall self-assessment question (scale 0–10), participants in the ARTZ group reported an average change of +2.55 (and +2.67 in a second period), while the DUROLANE group reported +2.70 (and +2.81). These figures are statistical estimates averaged across all measured time points using a modelling method, rather than simple averages. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00744471 · results posted 26 February 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 627 adults across four groups to study a drug called tanezumab (at three different doses — 2.5 mg, 5 mg, and 10 mg) compared with a placebo (an inactive treatment) in people with hip osteoarthritis. The trial measured three main things at 16 weeks: self-reported hip pain, physical function (how easily people could move and do daily activities), and participants' own overall assessment of how their osteoarthritis was affecting them. All three were measured using standard questionnaires scored on a 0–10 scale, where a higher number means more pain or worse function. It is worth noting that the large majority of participants in every group did not complete the full study period — for example, 143 out of 156 in the placebo group and between 145 and 152 in the tanezumab groups did not complete it. The reported data shows that at the start of the trial, average pain scores across all four groups were similar, sitting around 7.2–7.3 out of 10. By week 16, the placebo group's average pain score had decreased by 1.65 points, while the tanezumab groups showed decreases of 2.86 (2.5 mg), 3.35 (5 mg), and 3.37 (10 mg) points. For physical function, the placebo group's score dropped by 1.39 points, compared with drops of 2.54, 2.88, and 2.96 points in the three tanezumab groups. For the overall osteoarthritis assessment (rated 1–5, lower being better), the placebo group's score fell by 0.34 points, while the tanezumab groups fell by 0.67, 0.80, and 0.80 points respectively. Secondary measurements taken at other time points (weeks 2, 4, 8, 12, and 24) followed a broadly similar pattern, though some figures for certain time points were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT04419311 · results posted 21 February 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 66 people in total — 33 in each of two groups — all of whom were having knee replacement surgery. One person in one group did not complete the trial, so 65 people finished overall. The trial compared two different types of plastic insert used inside a knee replacement implant: an "ultra-congruent" insert and a "posterior cruciate ligament-stabilised" (PCL-stabilised) insert. The main thing being measured was the force the knee muscles could produce when bending and straightening the knee — recorded in Newton-metres (a unit of rotational force) — at three points in time: before surgery, and then at three and six months after surgery. The reported data shows the following average peak muscle-force readings for each group. Before surgery, the straightening (extensor) force was 55.56 Newton-metres for the ultra-congruent group and 58.33 for the PCL-stabilised group; the bending (flexor) force was 37.84 and 40.30 Newton-metres respectively. At three months after surgery, the reported extensor force was 44.38 (ultra-congruent) and 45.85 (PCL-stabilised); flexor force was 31.91 and 29.39. At six months after surgery, the reported extensor force was 53.53 (ultra-congruent) and 52.64 (PCL-stabilised); flexor force was 36.19 and 35.27. No secondary outcome data appears to have been reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03672370 · results posted 14 January 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03672370) involved 89 participants who all received a hip implant called the Alloclassic Variall Cup as part of hip replacement surgery. The trial was measuring two main things: how participants scored on a standard hip assessment tool called the Harris Hip Score, and how many participants still had their original implant in place over time (meaning it had not needed to be surgically revised or replaced). Of the 89 people who started the trial, 42 completed it, and 47 did not complete it — the reasons for not completing were not detailed in the data provided here. The reported data shows that, for the primary outcomes, the average Harris Hip Score among participants was 92.6 out of a possible 100 (where a score above 80 was defined in this trial as a "clinical success"). The reported data also shows that 98.63% of participants still had their original implant in place at the end of the follow-up period, based on a statistical method called Kaplan-Meier estimation (a way of tracking how long something lasts over time). For the secondary outcomes, the average Oxford Hip Score — another questionnaire measuring pain and daily function — was reported as 44.7 out of 48, where 48 is the best possible score. A general health questionnaire called the EQ-5D returned an average score of 0.9 out of 1, where 1 represents full health. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT04016259 · results posted 16 November 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT04016259) involved 30 people in total — 15 in a "sham" (inactive/dummy) group and 15 in a "self-administered CES" group. CES stands for Cranial Electrotherapy Stimulation, a device that delivers a very mild electrical current to the head. All 30 participants completed the trial. The study was measuring clinical pain levels in people with osteoarthritis of the knee, as well as how sensitive participants were to experimentally applied pain (such as heat and pressure). The reported data shows that for the main (primary) pain measures, the sham group scored 40.40 and the Self-CES group scored 27.33 on a numeric pain rating scale running from 0 (no pain) to 100 (worst imaginable pain). On a separate knee osteoarthritis symptom questionnaire (scored 0–96, with higher meaning worse symptoms), the sham group scored 47.40 and the Self-CES group scored 43.80. For the secondary measures — which looked at how participants responded to controlled heat and pressure applied during testing — the reported data shows the Self-CES group had higher heat pain thresholds (41.04°C vs 37.90°C) and tolerances (44.56°C vs 43.05°C), meaning they pressed the stop button at higher temperatures. For pressure pain threshold, the Self-CES group's figure was 2.59 kgf compared with 1.06 kgf in the sham group. A measure called conditioned pain modulation — which looks at how the body's own pain-dampening response reacts to a second pain stimulus — showed 3.64 kgf in the Self-CES group versus 1.93 kgf in the sham group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01451385 · results posted 17 September 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 376 people in total, with 285 completing the study and 91 not completing it. The trial was a single-group study — meaning all participants received the same study treatment — and it was primarily focused on tracking unwanted or unexpected health events (called adverse events) that occurred during the study. It also measured how participants rated their pain levels, how much their pain interfered with daily life, and — for those with hip or knee osteoarthritis — specific scores for pain and stiffness. The reported data shows that, out of 376 participants, 235 experienced at least one adverse event after starting the study drug, and 200 experienced what were classified as treatment-emergent adverse events (meaning health events that appeared after the first dose). Seventeen participants experienced serious adverse events, 73 stopped the study due to an adverse event, and two participants died during the study, though the reported data notes these deaths were considered unrelated to the study drug. Regarding pain, participants rated their average pain intensity at around 4.0 out of 10 at one recorded point and 2.4 out of 10 at another, on a scale where 0 means no pain and 10 means the worst pain imaginable. On average, participants reported approximately 67.7% pain relief from their medication. For those with hip or knee osteoarthritis, the reported pain score on the WOMAC questionnaire (which runs from 0 to 20, with higher meaning worse) was 6.22, and the stiffness score (0 to 8 scale) was 2.84. The pain interference score — measuring how much pain disrupted daily life on a 0–10 scale — was reported as 2.2. It is worth noting that because this trial had only one participant group and no comparison group, the reported data shows what was measured and recorded, but does not compare outcomes against a placebo or alternative treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02536833 · results posted 16 September 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02536833) enrolled 455 adults with knee osteoarthritis across four groups. Three groups received a single injection of different doses of an investigational medicine called SM04690 (either 0.03 mg, 0.07 mg, or 0.23 mg directly into the knee), while a fourth group received a placebo (inactive) injection. The trial was measuring changes in knee pain, physical function, and participants' own overall assessment of how they were doing, using standard questionnaires scored on a 0–100 scale. Around 402 of the 455 participants completed the study. The reported data shows that, on the main outcome — knee pain measured at 13 weeks using a standard questionnaire (where a lower score means less pain) — all four groups showed a reduction from their starting scores. The three SM04690 dose groups dropped by approximately 21 to 23 points, while the placebo group dropped by about 22 points, all on the 0–100 scale. At 26 weeks, the reported pain score reductions were similar across groups: roughly 23–27 points for the SM04690 groups and about 24 points for the placebo group. For physical function scores (also 0–100, lower meaning better function), the reported reductions at 13 weeks ranged from about 23 to 26 points across all groups, including placebo, and at 26 weeks ranged from roughly 24 to 29 points. Participants' own overall ratings of how they were doing also showed reductions across all groups at both time points, with the reported changes ranging from approximately 14 to 18 points at 13 weeks and 17 to 21 points at 26 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00653432 · results posted 1 September 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 184 people in the Monovisc® group and 185 in the saline (salt water injection) group, for a total of 369 participants. The trial was measuring knee pain and physical function in people with osteoarthritis of the knee. The main thing being measured was the proportion of participants whose knee pain score — recorded using a standard questionnaire called the WOMAC, which runs from 0 to 100 where higher means more pain — dropped by at least 40% and by at least 15 points from their starting score, over 12 weeks. The reported data shows that for the main outcome, 62.6% of people in the Monovisc® group and 56.1% in the saline group met that pain-reduction target over 12 weeks. For the secondary outcomes — which looked at how much scores changed from the start of the trial to week 12 — the reported data shows the following. Assessors' ratings of how much the knee was bothering participants dropped by an average of 28.6 points (Monovisc®) and 26.4 points (saline) on a 0–100 scale. Participants' own ratings of knee bother dropped by an average of 28.8 points (Monovisc®) and 28.9 points (saline). The physical function score dropped by an average of 24.1 points (Monovisc®) and 22.3 points (saline). Knee range of motion increased by an average of 1.5 degrees (Monovisc®) and 4.6 degrees (saline). A separate analysis — run after the main trial was complete and not part of the original plan — looked at whether at least a 50% pain reduction over 26 weeks was achieved; the reported data shows 44.4% of the Monovisc® group and 34.1% of the saline group met that threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03570554 · results posted 19 June 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03570554) enrolled 41 people across four groups, with 39 completing the study. It used a "crossover" design, meaning each participant tried all four treatments one after another in a different order — naproxen, extended-release acetaminophen (paracetamol), celecoxib, and a placebo (a dummy treatment with no active ingredient). The trial was measuring knee stiffness related to osteoarthritis using a patient-reported questionnaire called the Brief Arthritis Stiffness Scale (BASS), where scores run from 0 to 40 and a higher number means worse stiffness. The reported data shows that the primary measure was the total change in BASS stiffness scores added up across Days 2, 3, and 4 of each treatment period (compared to the starting score for that period). A negative number here means stiffness scores went down from where they started. The reported figures were: naproxen −12.6, extended-release acetaminophen −13.6, celecoxib −11.7, and placebo −2.3. For the secondary measure looking at the change in BASS score at Day 4 alone, the reported figures were: naproxen −5.2, extended-release acetaminophen −5.3, celecoxib −4.8, and placebo −1.3. The reported data also shows absolute (actual) BASS scores recorded at various time points across the treatment period, ranging roughly between 18 and 25 out of 40 across all four groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03381248 · results posted 22 May 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03381248) enrolled 177 people with knee pain — 89 in the cooled radiofrequency group and 88 in the hyaluronic acid (gel) injection group. The trial ran in two main phases: the first six months compared the two treatments directly, and from six to twelve months, most participants who had received the gel injection were given the option to cross over and receive the radiofrequency procedure instead. A smaller group of 36 participants from the radiofrequency arm continued into an extension phase lasting up to 24 months. The trial was primarily measuring how many people had their knee pain reduced by at least half, using a simple 0–10 pain rating scale, and also tracked how many people experienced unwanted side effects. The reported data shows that, at the six-month mark (the main comparison point), 54 out of 89 people in the cooled radiofrequency group reported a pain reduction of 50% or more on the rating scale, compared with 31 out of 88 in the gel injection group. A secondary pain measure at twelve months showed 43 out of the radiofrequency group still meeting that 50% reduction threshold, versus 10 in the gel injection group; among the 68 people who crossed over from gel injections to the radiofrequency procedure, 40 out of that crossover group met the same threshold at twelve months. For a separate questionnaire about overall knee function and stiffness (called the WOMAC, scored from 0 to 96 where lower is better), the reported average improvement from starting scores at six months was 31.5 points for the radiofrequency group and 14.8 points for the gel injection group; at twelve months those figures were 30.7 and 32.1 points respectively, with the crossover group showing an 18.1-point change. Regarding side effects, the reported data shows that 78 out of 89 radiofrequency participants, 48 out of 88 gel injection participants, and 38 out of 68 crossover participants experienced at least one adverse event — though the data as reported does not break down the nature or severity of those events in this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02540226 · results posted 25 March 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 66 people in total — 33 in a group that received tranexamic acid (a medicine used to reduce bleeding) through a drip into a vein, and 33 in a group that received the same medicine applied directly into the wound during knee surgery. The trial was primarily measuring a substance in the blood and wound fluid called plasmin anti-plasmin (PAP), which is a marker of how actively the body is breaking down blood clots — a process called fibrinolysis. By comparing the two groups, the researchers were looking at whether the way the medicine was delivered made a difference to this process and to other blood-related measures. The reported data shows that, for the main measurement taken from wound drainage fluid at four hours after the surgical tourniquet was released, the intravenous (drip) group had a PAP level of 117.8 µg/L, while the topical (applied into the wound) group had a level of 1,280.7 µg/L. When the same marker was measured in blood from the rest of the body, the levels were much closer: 1,032 µg/L for the intravenous group and 1,041.2 µg/L for the topical group. The reported data also shows that the level of tranexamic acid measured in the blood was higher in the intravenous group across multiple time points compared to the topical group. Calculated blood loss was reported as approximately 1,237 mL in the intravenous group and 1,405 mL in the topical group. Haemoglobin (a measure of red blood cells carrying oxygen) and haematocrit (the proportion of red blood cells in the blood) were also tracked at several time points, with the reported figures appearing broadly similar between the two groups across the measurement periods. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01066936 · results posted 6 March 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people who received a hip replacement implant called the MIS (Mini Stem). All participants started the study, but only 10 completed it — the other 10 did not finish, though the reasons are not detailed in the reported data. The trial was measuring bone mineral density (BMD) — that is, how dense or strong the bone is — in the thigh bone (femur) around the implant over time, using a type of scan called DEXA (Dual Energy X-Ray Absorptiometry). The thigh bone was divided into seven zones, and bone density in each zone was measured before surgery and then again at 3 months, 6 months, 1 year, and 2 years after the procedure. The reported data shows the average bone density readings (measured in grams per square centimetre) across the seven zones at each time point. Before surgery, the readings across the seven zones ranged from 0.8 to 2.0 g/cm². At 3 months after surgery, they ranged from 0.8 to 2.1 g/cm². The reported figures at 6 months, 1 year, and 2 years were broadly similar, ranging from 0.8 to approximately 2.2 g/cm² depending on the zone and time point. The outermost zone consistently recorded the lowest density reading (0.8 g/cm²) across all time points, while the middle zones recorded the highest readings. The reported data also includes a secondary measure called the Harris Hip Score, which is a tool scored from 0 to 100 that doctors use to assess how a person is functioning before or after hip surgery — a higher score means better function. Before surgery, the overall average score was reported as 49.5 out of 100, which falls in the "very poor" range on the scale. No post-surgery Harris Hip Score figures were included in the submitted results data, so those cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
-
NCT02698865 · results posted 4 March 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 220 people with knee osteoarthritis — 140 in the Monovisc group (a single-injection hyaluronic acid gel injected into the knee joint) and 80 in the saline (salt water) group. The saline group acted as a comparison. The trial was measuring changes in walking pain over time using a standard questionnaire called the WOMAC, where patients rate their pain on a scale from 0 (no pain) to 10 (extreme pain). Of those who started, 105 people in the Monovisc group and 47 in the saline group completed the full study. The reported data shows that, at the main measurement point — 180 days (about six months) after treatment — both groups reported lower walking pain scores compared to where they started. The Monovisc group's average score dropped by 1.75 points, while the saline group's average score dropped by 1.53 points on the 0–10 scale. The reported data also shows similar patterns at earlier check-ins: at day 14, the Monovisc group dropped by 1.44 points versus 1.16 for saline; at day 28, by 1.42 versus 1.13; at day 60, by 1.89 versus 1.75; and at day 120, by 1.97 versus 1.58. In plain terms, both groups reported some reduction in walking pain at every time point measured. It is worth noting that the data as reported does not include information on whether the differences between the two groups were considered statistically meaningful (that is, unlikely to be due to chance), so those figures alone cannot tell us whether any difference between the groups is significant. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03382262 · results posted 9 December 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT03382262) enrolled 55 people in total across four groups. Participants received either an experimental corticosteroid formulation called FX006 (32 mg) or a standard corticosteroid injection called TAcs (40 mg), given into either the shoulder or the hip joint. The trial was primarily measuring how much of the steroid medication appeared in the bloodstream over time, and also counting any unwanted health events (called adverse events) that occurred during the study period. The reported data shows that, for the shoulder groups, the peak amount of the active steroid ingredient detected in the blood was around 1,062–1,140 picograms per millilitre (a picogram is an extremely tiny unit of measurement) for the FX006 group, and around 1,104–1,502 picograms per millilitre for the TAcs group, depending on the time point measured. For the hip groups, the FX006 group had reported levels of around 682–752 picograms per millilitre, while the TAcs hip group showed notably higher levels, ranging from approximately 3,862 to 4,519 picograms per millilitre across the measured time points. Regarding unwanted health events, the reported data shows 10 events in the FX006 shoulder group, 7 in the TAcs shoulder group, 8 in the FX006 hip group, and 17 in the TAcs hip group. No further breakdown of what those events were is available in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01487200 · results posted 6 December 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01487200) enrolled 24 people in total, split across four groups. Five people received a low dose of FX006 (10 mg), seven received a medium dose (40 mg), seven received a high dose (60 mg), and five received a comparator injection called TCA IR (40 mg). FX006 and TCA IR are both forms of a corticosteroid called triamcinolone acetonide, but FX006 is a newer formulation designed to act locally in the joint. The trial was measuring how these treatments affected the body's natural cortisol levels — cortisol is a hormone your body produces naturally, and corticosteroid injections can temporarily lower it. The trial tracked this at several points: shortly after the injection, at two weeks, and at six weeks. The reported data shows that all four groups had lower cortisol levels compared to their starting point at each time point measured. For the primary measure — average cortisol in the blood over a 24-hour period — the drops were generally larger in the higher-dose FX006 groups and in the TCA IR group shortly after the injection. For example, shortly after the injection the TCA IR group showed a drop of 59.0 nmol/L, the 60 mg FX006 group dropped 62.2 nmol/L, the 40 mg group dropped 42.7 nmol/L, and the 10 mg group dropped 7.7 nmol/L. By six weeks, the drops across all groups were much smaller and closer together. The reported data also shows that the amount of the drug measured in the bloodstream (in pg/mL — picograms per millilitre, a very small unit of concentration) was substantially lower in all three FX006 groups compared to the TCA IR group at every time point measured. Similar patterns were reported for cortisol measured in urine. The secondary outcome measures — including cortisol measured in morning blood samples and in urine over 24 hours — also showed reductions from starting levels across all groups, with the reported numbers generally following a similar pattern to the primary outcomes. Where values moved upward or downward from one time point to the next varied between groups, and the reported data does not draw conclusions about which group fared better overall. It is worth noting that the groups were very small (as few as five people per group), which is typical for an early-phase trial focused on understanding how a drug behaves in the body rather than testing whether it treats a condition. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02610192 · results posted 2 December 2019
According to the results reported on ClinicalTrials.gov, this trial involved 50 people who received a single injection of a treatment called nSTRIDE APS (Autologous Protein Solution) into a knee affected by osteoarthritis. Of the 50 who started, 41 completed the study and 9 did not finish. The trial was measuring how participants rated their own knee pain, symptoms, daily functioning, sport and recreation ability, and quality of life over 12 months, using two well-known knee questionnaires. There was no comparison group — all participants received the same treatment. The reported data shows scores from a questionnaire called the KOOS, where a score of 100 means no problems at all and 0 means extreme problems. Before the injection, the pain score was reported at 40.3 out of 100. The reported scores at 1, 3, 6, and 12 months after the injection were 53.5, 52.5, 54.9, and 57.3 respectively. For symptoms, scores moved from a starting point of 46.9 to 62.5 at 12 months. Daily living function started at 45.9 and was reported at 62.0 at 12 months. Sport and recreation scores started at 11.2 and were reported at 22.9 at 12 months. Knee-related quality of life started at 29.7 and reached 38.2 at 12 months. A separate pain rating scale (where 0 means no pain and 10 means the worst possible pain) recorded an average score of 6.7 before the injection, which the reported data shows at 4.9, 5.0, 4.7, and 4.5 at 1, 3, 6, and 12 months after the injection. It is important to note that because this trial had no comparison group, the reported numbers alone cannot tell us what would have happened without the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02605876 · results posted 19 November 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02605876) enrolled 75 people in total, split evenly into three groups of 25: one group received whole body vibration, one received local muscle vibration (applied directly to the leg muscles), and one served as a control group. All 75 participants completed the study with no drop-outs. The trial was measuring several things related to knee health during walking, including how quickly force travels through the leg when the foot hits the ground (called "loading rate"), the strength of the thigh muscles (quadriceps), and how well participants could sense the position of their knee in space (proprioception). These were all measured as the *change* from before to after the intervention. The reported data shows the following changes across the four primary outcomes. For the linear ground reaction force loading rate (how force builds through the leg during walking), the whole body vibration group changed by +0.276 multiples of body weight per second, the local muscle vibration group by −0.146, and the control group by −0.135. For quadriceps (thigh muscle) strength, the changes were +0.05, −0.13, and −0.09 Newton·meters per kilogram respectively. For knee proprioception (sense of knee position, measured in degrees of error — where a smaller number means better accuracy), the changes were −0.71 degrees, −0.61 degrees, and −0.08 degrees. For the instantaneous loading rate (a different way of measuring force through the leg at peak), the changes were −0.333, −3.552, and +0.473 multiples of body weight per second. For the two secondary outcomes, the reported data shows changes in knee extension moment (a measure related to thigh muscle activity during walking) of +0.271, +0.014, and −0.17 percent of body weight times height, and changes in knee valgus moment (related to side-to-side loading of the inner knee) of −0.450, −0.436, and −0.304 percent of body weight times height, for the whole body vibration, local muscle vibration, and control groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02315664 · results posted 28 October 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 61 people in total — 30 in an "Immediate Intervention" group and 31 in a "Delayed Intervention" group. By the end of the study, 29 and 27 people in each group respectively had completed the trial. The trial was measuring physical activity levels in people with knee osteoarthritis (a condition where the cartilage in the knee joint wears down), tracking how much time participants spent doing moderate-to-vigorous physical activity, how much time they spent being sedentary (sitting or resting for long stretches), and how their knee symptoms, pain, and daily functioning scored on a standard knee health questionnaire. Participants wore a movement-tracking device for seven days at the start of the study and again at two, four, and six months. The reported data shows that, for the main outcome — daily minutes of moderate-to-vigorous physical activity — the Immediate Intervention group recorded averages of 62.1, 75.5, 62.6, and 65.6 minutes per day across the four measurement points, while the Delayed Intervention group recorded 65.3, 50.0, 60.1, and 70.7 minutes per day at those same time points. For sedentary time, the Immediate Intervention group recorded averages of 464.1, 437.6, 505.9, and 435.8 minutes per day, compared with 497.4, 503.0, 508.9, and 496.0 minutes per day for the Delayed Intervention group. For the knee health questionnaire (scored from 0 to 100, where higher means better), the reported data shows scores across the four time points ranging roughly from the low-to-mid 60s up to the mid-70s for both groups across the pain, symptoms, and daily activity categories, and in the upper 40s to low 50s for the sports and recreation category. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02593864 · results posted 22 October 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people who wore a variable-stiffness shoe — a specially designed shoe with soles that can flex at different levels of firmness. The trial was looking at two main things: how the shoe affected the load passing through the inner part of the knee while walking (called the "knee adduction moment"), and how it affected a protein in the blood called COMP, which is linked to cartilage activity in the joints. Of the 25 people who started, 19 completed the study, and 6 did not finish. The reported data shows that, after six months of wearing the variable-stiffness shoe, the knee load measurement changed by minus 0.19 units (expressed as a percentage of each person's body weight multiplied by their height — a standard way of comparing people of different sizes). A negative number here means the measurement was lower at six months than at the start. For the blood protein (COMP), which was measured before and after a 30-minute walk, the reported data shows a change of minus 0.8 percent of the resting level, again meaning the value was slightly lower at six months compared to the beginning of the study. No other outcome data appears to have been reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02958267 · results posted 24 September 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people with knee problems — 17 in a group receiving a bone marrow and platelet-rich plasma (BMAC + PRP) injection, and 15 in a group receiving a hyaluronic acid gel injection called Gel-One®. Two people in the BMAC + PRP group did not go on to receive their treatment, so 15 in each group actually completed the injections. By the end of the 12-month follow-up, 13 people remained in the BMAC + PRP group and 14 in the Gel-One® group. The trial was measuring changes in knee pain, symptoms, and function using several questionnaires over time. The reported data shows that the main outcome was the Knee Injury and Osteoarthritis Outcome Score (KOOS), which covers five areas — pain, symptoms, daily activities, sport and recreation, and quality of life — each scored from 0 to 100, where higher means better. The numbers reported appear to represent changes in scores across these five areas and an overall figure at various points in time, with both groups showing positive changes in most areas. For the pain scale (scored 0–10, where lower is better), the reported change scores were around −1.9 to −3.1 for the BMAC + PRP group and −1.6 to −1.9 for the Gel-One® group across the follow-up periods, indicating reductions in reported pain scores in both groups. A general health questionnaire (PROMIS Global Health) was also measured; the reported data shows mixed changes across both groups for physical and mental health sub-scores at the different time points, with figures ranging from small negative changes to positive changes in both groups. The reported data shows results from a relatively small number of participants, and the trial's records on ClinicalTrials.gov do not include information that would allow a direct statistical comparison between the two groups to be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT03714659 · results posted 11 September 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people in a single intervention group, with 19 completing the study and 1 not completing it. The trial was measuring changes in knee pain and overall knee function in people with a meniscal injury (a tear or damage to the cartilage cushioning inside the knee joint). The reported data shows that, on average, participants' self-reported knee pain score dropped by 3.2 points on a scale from 0 (no pain) to 10 (worst possible pain). For the second set of measurements, the trial used a knee function questionnaire that looks at five different areas — pain, other symptoms, day-to-day activities, sport and recreation, and quality of life — where a higher score (out of 100) means fewer problems. The reported data shows average improvements across all five areas: 17.5 points for pain, 17.3 points for other symptoms, 20.5 points for day-to-day activities, 26.3 points for sport and recreation, and 28.4 points for quality of life. It is worth noting that because there was no comparison group (for example, a group receiving a different treatment or no treatment), these numbers reflect changes within the one group of participants only. No data was reported separately for the one person who did not complete the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02705625 · results posted 17 June 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 244 adults with knee osteoarthritis across three groups: 82 received a 100 mg daily dose of an investigational drug called MIV-711, 82 received a 200 mg daily dose of MIV-711, and 80 received a placebo (a dummy treatment with no active ingredient). The trial ran for 26 weeks and was measuring changes in knee pain scores, as well as changes in knee bone area and cartilage thickness seen on MRI scans. By the end of the study, 74, 72, and 69 participants completed the trial in each respective group. The reported data shows that for the primary outcome — average knee pain rated on a scale of 0 (no pain) to 10 (worst possible pain) — all three groups reported a reduction from their starting scores after 26 weeks. The 100 mg MIV-711 group reported an average reduction of 1.7 points, the 200 mg group a reduction of 1.5 points, and the placebo group a reduction of 1.3 points. For the MRI bone area measurements, the placebo group showed a larger average increase in bone area (23.2 mm²) compared to the 100 mg group (8.1 mm²) and 200 mg group (8.2 mm²). For cartilage thickness at the femur (thigh bone), the placebo group showed an average decrease of 0.066 mm, while the 100 mg group showed a very small average increase of 0.008 mm and the 200 mg group a small average decrease of 0.017 mm. The reported data also shows changes in WOMAC scores — a standardised questionnaire (scored 0–100) used to assess knee pain, stiffness, and difficulty with daily activities, where lower scores indicate less difficulty. All three groups reported reductions across all three WOMAC categories over 26 weeks. For pain, the 100 mg group reported an average reduction of 16.6 points, the 200 mg group 13.0 points, and the placebo group 9.8 points. For stiffness, reductions were 17.0, 14.5, and 9.8 points respectively. For difficulty with daily activities, reductions were 16.4, 14.0, and 9.9 points respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00740376 · results posted 13 June 2019
According to the results reported on ClinicalTrials.gov, this trial looked at two types of partial knee replacement implants — a mobile bearing version (MBK) and a fixed bearing version (FBK) — used in people with knee problems affecting only one part of the joint. A total of 37 people were enrolled: 22 received the MBK implant and 15 received the FBK implant. Over the two years of follow-up, 19 people in the MBK group and 12 in the FBK group completed the study, with three people in each group not completing it. The reported data shows that the main thing being measured was how many implants met a combined set of success criteria at the two-year mark — covering knee function scores, X-ray findings, and whether any implant had needed to be removed or replaced. According to the results reported on ClinicalTrials.gov, 17 out of 22 MBK implants and 15 out of 15 FBK implants met these criteria. For the secondary measures, both groups were scored on several knee questionnaires at two years. On the American Knee Society Score (a 0–100 scale where higher is better), the MBK group scored 95.50 overall and the FBK group scored 94.74. On the Hospital for Special Surgery score (also 0–100, higher is better), the MBK group scored 95.25 and the FBK group scored 93.63. On the Knee Injury and Osteoarthritis Outcome Score, which covers pain, symptoms, daily activities, sport, and quality of life (all 0–100, higher is better), both groups recorded scores in the 60s to low 90s across the five areas, with the two groups' numbers sitting close to each other in every category. The reported data also shows that 3 MBK implants were recorded as having a device-related complication, compared with 0 in the FBK group; the survival curve data (a method of tracking how long implants lasted without needing replacement) was not reported as a percentage in the submitted data, so a specific survival rate figure cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03623035 · results posted 5 June 2019
According to the results reported on ClinicalTrials.gov, this trial involved 10 participants, all of whom completed the study. There was only one group — the Lumbar Plexus Block Group — meaning all participants received the same treatment (a type of nerve-blocking procedure in the lower back area). The trial was measuring pain levels and nerve sensation recovery after the procedure. The reported data shows that when participants sat up in bed (pain with activity), the average pain score was 1.4 out of 10, where 0 means no pain and 10 means the worst possible pain. When participants were lying still (pain at rest), the average pain score reported was 1 out of 10. For the third measurement, 9 out of 10 participants were reported to have regained normal pin-prick sensation — meaning they could feel a sharp touch — below a certain point in the lower spine, which was used as a sign that the nerve block had worn off in that area. It is worth noting that this was a very small study with only 10 participants and no comparison group, so the reported numbers reflect only the experiences of this small sample. No data was reported for any comparison or control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02192190 · results posted 8 November 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 268 people across six groups to study osteoarthritis knee pain. Participants were assigned to receive either a placebo (a dummy treatment), celecoxib (an existing pain medicine used as a comparison), or one of four doses of an investigational medicine called LY2951742 (5 mg, 50 mg, 120 mg, or 300 mg). The main thing being measured was how much self-reported knee pain changed over eight weeks, using a standard questionnaire called the WOMAC, where scores run from 0 (very good) to 100 (very poor) — so a drop in score means participants reported less pain. The reported data shows that all six groups had lower pain scores at eight weeks compared to where they started. For the main pain measure, the placebo group's score dropped by an average of 19.2 points, the celecoxib group dropped by 31.3 points, and the four LY2951742 groups dropped by 16.4, 24.2, 21.8, and 17.7 points respectively (at the 5 mg, 50 mg, 120 mg, and 300 mg doses). The reported data also shows similar patterns across the secondary measures — including physical function, joint stiffness, overall osteoarthritis assessment, and a combined total score — with all groups showing reductions from their starting scores over the eight weeks. For the measure counting how many participants met a set threshold of meaningful improvement, the numbers reported were: placebo 21, celecoxib 14, LY2951742 5 mg 7, 50 mg 15, 120 mg 10, and 300 mg 10 participants. It is also worth noting that a large proportion of participants did not complete the study across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02068599 · results posted 23 October 2018
According to the results reported on ClinicalTrials.gov, this trial tested two strengths of a topical (applied to the skin) treatment called TV-45070 — a 4% version and an 8% version — compared with a placebo (an inactive look-alike) in people with knee osteoarthritis pain. A total of 389 people were enrolled across three groups: 130 in the 4% group, 129 in the 8% group, and 130 in the placebo group. The trial measured changes in self-reported knee pain and physical function using a standard questionnaire called the WOMAC, where lower scores mean less pain or stiffness. The main thing being measured was how much evening pain when walking changed from the start of the trial to the last five days of treatment. The reported data shows that for the primary measure — change in evening walking pain on a 0–100 scale — all three groups recorded reductions from their starting scores. The 4% TV-45070 group reported a reduction of about 20.6 points, the 8% group reported a reduction of about 23.1 points, and the placebo group reported a reduction of about 24.8 points. Similar patterns were seen across the secondary measures. For the broader five-question pain score (out of 500), reductions were approximately 99.7 (4%), 108.5 (8%), and 117.5 (placebo). For morning walking pain, stiffness, and physical function scores, all three groups also showed reductions, with the reported numbers varying across groups without a consistent pattern favouring either active treatment over placebo. The reported data also shows the proportion of participants who experienced at least a 30% reduction in evening walking pain: approximately 45% in the 4% group, 43.8% in the 8% group, and 46.9% in the placebo group. For at least a 50% reduction, the figures were approximately 48.8%, 52.3%, and 45.4% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT03050320 · results posted 10 August 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT03050320) involved 43 people in total — 21 in an exercise group and 22 in a no-exercise group. One person from each group did not complete the study. The trial was measuring changes in lower limb function, joint pain, upper limb symptoms, muscle strength, grip strength, and cardiovascular fitness in people with osteoarthritis, comparing those who did an exercise programme against those who did not. The reported data shows that the main outcome — a self-reported physical function score called the Lower Extremity Functional Scale (scored from 0 to 80, where higher is better) — changed by +5.3 points on average in the exercise group and by −1.6 points in the no-exercise group over the course of the trial. For pain scores related to the knee and hip (measured on several different questionnaires), the reported data shows small changes in both directions across both groups; for example, one knee pain score changed by +3.3 in the exercise group and −0.1 in the no-exercise group, while an intermittent pain score changed by −6.1 in the exercise group and −2.4 in the no-exercise group. For upper limb symptoms, the exercise group showed a change of −1.6 and the no-exercise group +0.2 (where lower scores indicate fewer problems). Knee muscle strength showed a reported change of +0.15 Newton-metres per kilogram for knee extension in the exercise group compared with 0.00 in the no-exercise group. Grip strength and cardiovascular fitness (an estimated measure of how efficiently the body uses oxygen during exercise) also showed small differences between the groups, with the reported data showing a cardiovascular fitness change of +1.0 mL/kg/min in the exercise group versus +0.1 in the no-exercise group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02462148 · results posted 7 August 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 85 people in total across three groups. Thirty-seven people received a 4 mg dose of a medication called dexamethasone injected near a nerve (the "perineural" route), 36 people received a 1 mg dose the same way, and 12 people received a placebo (an inactive substance). All but one participant — who was in the 4 mg group — completed the study. The trial was measuring how long a nerve block (temporary numbing of a nerve used for pain management after surgery) lasted, as well as pain scores, nausea and vomiting, nerve-related complications, and the amount of pain relief medication used after surgery. The reported data shows that the average time until the nerve block wore off was approximately 37 hours in the 4 mg group, about 31.75 hours in the 1 mg group, and about 29.67 hours in the placebo group. For pain scores (rated 0–10, where 0 means no pain and 10 means the worst possible pain), the reported numbers at various time points ranged roughly between 0.8 and 3.3 across all three groups. The reported data shows that 5 people in the 4 mg group, 14 in the 1 mg group, and 4 in the placebo group experienced nausea and vomiting after surgery. No neurological complications (such as unusual tingling or nerve-related symptoms) were recorded in any group. For pain relief medication use after surgery, the reported average was about 27 mg of oxycodone equivalents in the 4 mg group, 26 mg in the 1 mg group, and 42 mg in the placebo group. The time until a patient first asked for pain relief medication was reported as approximately 686 minutes in the 4 mg group, 655 minutes in the 1 mg group, and 658 minutes in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02161484 · results posted 29 March 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people in total — 5 in a group receiving a combined continuous lumbar plexus block with a parasacral nerve block, and 5 in a group receiving a lumbar plexus nerve block alone. Both approaches are types of regional nerve pain relief used around the time of surgery. The trial was measuring post-operative pain levels, as well as how much pain relief medication participants needed afterwards. The reported data shows that pain was scored on an 11-point scale (0 = no pain, 10 = worst pain imaginable), measured both during physical therapy sessions and while at rest. Across three separate measurement time points, the combined block group recorded during-therapy pain scores of 2.6, 4.25, and 1.0, while the lumbar-plexus-only group scored 3.6, 2.2, and 2.0 at those same points. For pain at rest, the combined block group scored 3.5, 7.25, and 8.0, compared with 5.0, 4.4, and 5.0 in the lumbar-plexus-only group. It is worth noting that very few participants completed the study — only 1 person in the combined block group and 2 in the lumbar-plexus-only group finished, out of 5 in each group — which means these numbers come from a very small set of people. For the secondary outcomes — including the number of nurse-administered pain relief doses and the total amount of opioid pain medication used over 48 hours — the reported data shows no results were submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02357459 · results posted 1 February 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 486 adults across three groups: 161 received a treatment called FX006 (a 32 mg injection), 163 received a placebo (an inactive injection), and 162 received a comparator treatment called TCA IR (40 mg, another type of injection). The trial was measuring changes in knee pain over 12 to 24 weeks, using an 11-point scale where 0 means no pain and 10 means the worst pain imaginable. By the end of the study, 144, 149, and 150 participants in each group respectively had completed the trial. The reported data shows that the main result — measured at 12 weeks — was the change in average daily pain scores from the start of the trial. The FX006 group reported an average reduction of 3.12 points on the pain scale, compared to a reduction of 2.14 points in the placebo group, and 2.86 points in the TCA IR group. The trial also tracked pain scores across the full 24-week period using a combined measure (essentially adding up the week-by-week pain changes over time); the reported figures for this longer period were -432.5 for FX006 and -297.0 for placebo. All three groups reported reductions in pain scores from their starting point, with the size of those reductions varying between groups as described above. Additional measurements taken at individual weekly time points throughout the study showed a similar pattern of reported changes across all three groups, with figures ranging roughly between -1.0 and -3.2 points on the pain scale depending on the week and the group. The reported data shows numbers only — it does not on its own tell us whether any differences between groups are meaningful in a broader sense, and no safety or side-effect data was included in the results provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01487161 · results posted 12 January 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 229 adults across four groups. Three groups received different doses of an investigational knee injection called FX006 (10 mg, 40 mg, or 60 mg), while a fourth group received a comparator injection called TCA IR at 40 mg (a standard corticosteroid). The trial was primarily measuring changes in daily knee pain scores over 12 weeks, using an 11-point scale where 0 means no pain and 10 means the worst pain imaginable. The vast majority of participants completed the study — only seven people across all four groups did not finish. The reported data shows that at week 8, the 60 mg FX006 group's average pain score had dropped by 3.9 points from where it started, compared to a drop of 3.4 points in the TCA IR group. By week 10, those figures were 3.6 and 3.3 respectively, and by week 12 they were 3.2 and 3.3. The reported data also shows results for the lower FX006 doses compared to TCA IR: at week 8, the 10 mg group showed a drop of 3.9 points and the 40 mg group showed a drop of 4.3 points, against 3.4 points for TCA IR. A separate questionnaire measuring knee pain, stiffness, and physical function (called the WOMAC) was also completed at week 8; the reported score changes on the pain portion of that questionnaire ranged from −0.96 to −1.33 across the four groups, on a 0–4 scale where higher scores represent worse pain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02576249 · results posted 21 July 2017
According to the results reported on ClinicalTrials.gov, this trial involved 29 people with knee problems who were divided into two groups. Fifteen participants received an injection of ropivacaine (a local anaesthetic) combined with methylprednisolone (a steroid), while 14 received a saline (salt water) solution combined with methylprednisolone. All 29 participants completed the trial. The study was measuring knee pain, activity levels, and overall knee-related quality of life using three different questionnaires or rating tools. The reported data shows the following numbers. On the main outcome — the Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale, where 0 means extreme knee problems and 100 means no knee problems — the ropivacaine-and-steroid group scored 63.1 and the saline-and-steroid group scored 67.2. For pain measured on a 0–10 scale (where 0 is no pain and 10 is unbearable pain), the reported data shows scores were recorded at rest and during activity, before the injection and at several follow-up points. Before the injection, pain scores were similar between groups (around 6.4 and 5.8). Immediately after the injection, the ropivacaine group reported lower pain scores (2.4 versus 4.0 at rest; 1.9 versus 2.4 with activity). At later time points — 2 weeks and 3 months — the numbers between groups were closer together. On the Tegner Activity Scale (0–10, where higher numbers reflect more active lifestyles), the ropivacaine group recorded scores of 3.5, 4.3, and 3.5 across the measurement points, while the saline group recorded 3.0, 3.2, and 3.0. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT02512393 · results posted 11 July 2017
According to the results reported on ClinicalTrials.gov, this trial involved 41 people in total — 21 in the active tDCS (transcranial direct current stimulation, a form of mild electrical brain stimulation) group and 20 in a sham (dummy/inactive) tDCS group. Forty of the 41 participants completed the study. The trial was measuring self-reported pain levels in people with osteoarthritis using three different pain questionnaires, comparing those who received the real stimulation against those who received the inactive version. The reported data shows the following numbers across the three pain scales. On the Numeric Rating Scale (a 0–100 pain score, where higher means more pain), the active group scored 27.25 and the sham group scored 19.00 at one time point, and 8.75 versus 12.55 at another time point. On the WOMAC Pain Subscale (a joint-specific pain and function questionnaire, where higher scores mean worse pain), the active group scored 29.30 and the sham group 20.40 at one time point, and 24.20 versus 19.50 at another. On the Short-Form McGill Pain Questionnaire (a 0–10 scale, higher meaning worse pain), the active group scored 2.25 and the sham group 1.50 at one time point, and 1.29 versus 1.60 at another. The reported data does not specify which time points these measurements correspond to, so further context was not available to clarify the order or timing of these results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT02311881 · results posted 7 April 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 708 people in total across three groups: 235 taking paracetamol 4,000 mg per day split into two doses, 236 taking paracetamol 3,990 mg per day split into three doses, and 237 taking a placebo (a dummy tablet with no active ingredient). The trial ran for 12 weeks and was primarily measuring changes in joint pain in people with osteoarthritis, using a standard questionnaire called the WOMAC. This questionnaire asks participants to rate their pain, physical function (how easily they can do everyday activities), and joint stiffness on a scale from 0 to 100 mm, where a lower score means less pain or difficulty. The reported data shows that for the main measure — pain scores over 12 weeks — all three groups reported reductions from their starting scores. The twice-daily paracetamol group reported an average reduction of about 28.3 mm, the three-times-daily paracetamol group reported a reduction of about 25.9 mm, and the placebo group reported a reduction of about 25.7 mm. Similar patterns were reported for physical function and stiffness scores, with all three groups showing reductions of roughly 26–28 mm. For the overall WOMAC total index (measured on a 0–1 scale), all three groups reported a change of approximately -0.26 to -0.28. The reported data also shows that the number of participants classified as "responders" — meaning they met certain improvement thresholds — was 157 in the twice-daily paracetamol group, 148 in the three-times-daily group, and 159 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01831219 · results posted 11 January 2017
According to the results reported on ClinicalTrials.gov, this trial compared two approaches to hip replacement surgery: one using a robotic system called ROBODOC and one using conventional (standard) surgical techniques. A total of 73 people were enrolled in the ROBODOC group and 45 in the conventional group. However, not everyone completed the study — 40 people in the ROBODOC group and 21 in the conventional group finished. The trial measured bone changes around the implant on X-rays, as well as participants' pain, stiffness, physical function, and general health using several scored questionnaires. The reported data shows that for the two primary outcomes, both groups had 2 hips showing signs of osteolysis (bone loss around the implant, visible on X-ray). On the WOMAC questionnaire — which measures pain, stiffness, and physical limitation on a scale where 96 is the best possible score — the ROBODOC group recorded an average score of 8.44 and the conventional group recorded 11.32. For the secondary outcomes, the Harris Hip Score (out of 100, higher is better) came in at 93.49 for ROBODOC and 89.50 for conventional. The general health questionnaire (HSQ-12, out of 800, higher is better) showed 683.52 for ROBODOC and 637.16 for conventional. The UCLA Activity Score (out of 10, higher is better) was 6.09 for ROBODOC and 5.71 for conventional. The pain Visual Analogue Scale (a 0–100 scale where 0 means no pain and 100 means the worst imaginable pain) recorded 4.69 for ROBODOC and 6.42 for conventional. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00565812 · results posted 30 December 2016
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called SD-6010 in people with knee osteoarthritis (a condition where the cartilage in the knee gradually wears down). A total of 1,457 people took part — 485 received the lower dose (50 mg), 486 received the higher dose (200 mg), and 486 received a placebo (a dummy treatment with no active ingredient). The trial ran for two years. The main thing being measured was how quickly the gap between the bones in the knee (called the "joint space") narrowed over time, as shown on X-rays — a narrower gap suggests the condition is getting worse. Participants also completed questionnaires about their pain, stiffness, and physical function. The reported data shows that in all three groups, the joint space narrowed slightly over the two years. For the overall group, the rate of narrowing was reported as −0.101 mm per year for the 50 mg group, −0.125 mm per year for the 200 mg group, and −0.109 mm per year for the placebo group (negative numbers mean the joint space got smaller, i.e., things got slightly worse over time). When the results were broken down by how severe participants' arthritis was at the start, the numbers were similar across all three groups in both the milder and more severe subgroups. For the questionnaire scores measuring pain, stiffness, and physical function (rated on a scale where higher scores mean worse symptoms), all three groups reported lower — that is, improved — scores over the course of the study, with changes of a broadly similar size across the 50 mg, 200 mg, and placebo groups at each time point measured. It is worth noting that data for some of the later time points (months 18 and 24) in the questionnaire outcomes were not fully reported in the submitted results, so a complete picture across all time points is not available from this data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01618708 · results posted 11 July 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 175 people in the placebo group and 182 people in the Synvisc-One group, for a total of 357 participants. The trial was looking at hip osteoarthritis — a condition where the hip joint wears down over time — and measured whether a single injection of Synvisc-One (a gel-like substance injected into the joint) made a difference compared to a placebo injection (an inactive substance). The main thing being measured was how much walking pain changed over 26 weeks, using a standard questionnaire called the WOMAC, where patients rated their pain on a scale from 0 (no pain) to 10 (extreme pain). The reported data shows that, on average, both groups reported a reduction in their walking pain score over 26 weeks. The placebo group's score dropped by 2.26 points, while the Synvisc-One group's score dropped by 2.19 points — figures that were very close to each other. For the broader pain score (covering all types of pain, not just walking), the reported changes were again similar: a drop of 2.26 points in the placebo group and 2.19 points in the Synvisc-One group. Patients' own overall ratings of their hip condition also followed a similar pattern, with the placebo group reporting a drop of 2.06 points and the Synvisc-One group a drop of 2.00 points. When looking at the proportion of people who reported at least a 2-point improvement in walking pain — considered a meaningful change — the reported data shows 45.71% in the placebo group and 45.05% in the Synvisc-One group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01586338 · results posted 24 February 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 237 people who received an injection treatment called Synvisc (a gel-like substance injected into the knee joint) for knee osteoarthritis. Of those, 229 people completed the study and 8 did not finish. The trial was measuring changes in knee pain during walking, overall knee pain, stiffness and physical function scores (using a questionnaire called the WOMAC), as well as how both participants and their doctors rated the knee condition over time. The study also tracked any unwanted or unexpected symptoms or health events (called adverse events) that occurred during the trial period. The reported data shows that on the WOMAC walking-pain score (measured on a scale of 0–100, where higher numbers mean more pain), the average score decreased by 26.0 points at week 8, 30.0 points at week 12, and 33.0 points at week 26 from where participants started. Broader scores covering overall pain, stiffness, and physical function also showed reductions across the same time points. For participants' own ratings of their knee condition at week 26, the reported data shows approximately 5% rated it "very well," 44% "well," and the remainder across "fair," "poor," or "very poor" — with a broadly similar pattern seen in doctors' ratings. Regarding adverse events, the reported data shows that 27.8% of participants experienced at least one unwanted health event during the study period, and 1.7% experienced a serious adverse event (one serious enough to cause hospitalisation, be life-threatening, or result in significant disability). One participant (0.4%) was also recorded in a separate adverse event category. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00850538 · results posted 4 December 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 101 participants in total. Of those, 60 people completed the study, while 41 did not finish. The trial was focused on collecting biological specimens (samples) from participants that could be used for genetic analysis — that is, examining DNA or related material to look for patterns or markers of interest. The reported data shows that the primary thing being measured was how many participants provided samples that were suitable ("viable") for genetic analysis. Out of all the participants involved, the results indicate that only 14 provided specimens that could actually be used for this purpose. No other outcome measures appear to have been reported in the submitted data, so no further numbers are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01855958 · results posted 22 September 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01855958) enrolled 26 people in total — 13 in a group receiving a treatment called DIMST (Deep Intramuscular Stimulation Therapy) and 13 in a comparison group that received a sham (inactive/dummy) version of the treatment using rubber electrodes. Twenty-five of the 26 participants completed the trial. The study was measuring pressure pain thresholds (how much pressure a person could tolerate before feeling pain) and brain signal activity, as well as self-reported pain levels. The reported data shows the following numbers after the intervention. For the two primary (main) outcomes: the pain pressure threshold — a measure of how much physical pressure caused pain — was recorded at 8.82 kgf/cm² in the DIMST group and 6.66 kgf/cm² in the sham group; and a brain signal measure called Motor Evoked Potential (an electrical signal produced in a muscle when the brain is stimulated) was 1.14 millivolts in the DIMST group and 1.12 millivolts in the sham group. For the secondary (additional) outcomes: self-reported pain intensity on a 0–10 scale was 0.88 in the DIMST group and 3.36 in the sham group; two measures of brain signal regulation (Intracortical Inhibition and Intracortical Facilitation, which reflect how the brain's motor area controls its own activity) were 0.75 and 1.20 respectively in the DIMST group, compared with 0.57 and 0.78 in the sham group; and a brain timing measure called the Cortical Silent Period (the brief pause in muscle activity after a brain stimulus) was 50.93 milliseconds in the DIMST group and 48.92 milliseconds in the sham group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01440972 · results posted 30 July 2015
According to the results reported on ClinicalTrials.gov, this trial involved 45 people in total — 24 assigned to exercise without a technique called partial blood flow restriction (PBFR), and 21 assigned to exercise with PBFR. PBFR involves using a cuff or wrap to partially reduce blood flow to the limbs during exercise. The trial was measuring whether adding this technique to exercise made a difference to leg strength, muscle size, muscle power, and knee pain in participants. The reported data shows the following changes from the start to the end of the trial. For the main measure — leg-press strength relative to body weight — the exercise-without-PBFR group showed a reported change of 0.2 kg per kg of body mass, while the exercise-with-PBFR group showed a change of 0.4 kg per kg of body mass. For the secondary measures: thigh muscle size (measured by MRI scan) showed a reported percentage change of 0.01% in the no-PBFR group and 1.3% in the PBFR group. Leg muscle power changed by 0.42 watts in the no-PBFR group and 0.62 watts in the PBFR group. A knee pain score (where higher numbers mean less pain, on a scale of 0–100) changed by 1.8 points in the no-PBFR group and 2.0 points in the PBFR group. Knee extensor (straightening) strength showed a reported change of −0.05 Nm/kg in the no-PBFR group and 0.07 Nm/kg in the PBFR group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01801735 · results posted 12 May 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 600 people, all of whom received meloxicam 10 mg. The trial ran for up to 52 weeks. Of the 600 who started, 390 completed the study and 210 did not finish. The trial was measuring how often participants experienced adverse events (unwanted medical occurrences) while taking the medication — this was the primary thing the researchers were tracking. The reported data shows the following numbers related to adverse events over the course of the study: 406 out of 600 participants experienced at least one treatment-emergent adverse event (meaning an unwanted medical occurrence that appeared or worsened after starting the medication). Of those, 23 participants experienced a severe treatment-emergent adverse event, and 35 experienced what is classified as a serious adverse event (a more significant medical occurrence). The data also shows that 127 participants had an adverse event considered by investigators to be related to the treatment, 79 participants stopped the study early because of an adverse event, and 2 participants died during the study period. No secondary outcome measure data was included in the results submitted to ClinicalTrials.gov. It is worth noting that adverse event numbers alone do not tell us whether events were caused by the medication, and no comparison group (such as a placebo or alternative treatment) was included in this trial, so the reported data shows only what was observed in this single group of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00549172 · results posted 23 March 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT00549172) enrolled 146 adults — 70 in a surgical ("Operative") group and 76 in a non-surgical ("Conservative") group — and all participants completed the study. The trial was measuring knee function, knee pain, and quality of life in people with a meniscal tear (a tear in the cartilage of the knee), comparing those who had surgery with those who did not. The reported data shows the following scores at the end of the study. On the Lysholm Knee Score — a questionnaire about knee function in daily life, rated 0–100 where higher means fewer symptoms — the Operative group scored 82.2 and the Conservative group scored 83.4. On the WOMET scale — another knee-specific quality-of-life questionnaire also scored 0–100 where 100 is the best possible result — the Operative group scored 81.0 and the Conservative group scored 79.9. For knee pain after exercise, rated on a 0–10 scale where 0 means no pain and 10 means extreme pain, the Operative group reported 2.7 and the Conservative group reported 2.9. Pain at rest on the same 0–10 scale was reported as 1.6 for the Operative group and 1.9 for the Conservative group. On a general quality-of-life measure (the 15-D, scored 0–1 where 1 represents full health), both groups scored similarly at 0.94 and 0.92 respectively. The reported data also included a cost-effectiveness measure comparing the two approaches, but no numerical results were submitted to ClinicalTrials.gov for that outcome, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00865046 · results posted 26 January 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 190 people across three groups (Arm 1: 63 people, Arm 2: 64 people, and Arm 3: 63 people). The trial was measuring knee or hip osteoarthritis symptoms using a standard questionnaire called the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index). This tool asks participants about their pain, joint stiffness, and physical function, with a total score ranging from 0 (best possible) to 96 (worst possible). The primary focus reported here was the pain portion of that questionnaire, which is scored from 0 to 20. The reported data shows that by the end of the study, most participants completed the trial — 57 from Arm 1, 59 from Arm 2, and 62 from Arm 3. For the pain score, the reported average results were 6.1 out of 20 for Arm 1, 6.6 out of 20 for Arm 2, and 7.9 out of 20 for Arm 3 — where a lower number represents less pain reported on the scale. No secondary outcome measures or additional breakdown of the WOMAC subscales (stiffness or physical function) were included in the data submitted to ClinicalTrials.gov, so those figures cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01245283 · results posted 8 October 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 90 people with osteoarthritis across three groups: 32 were placed on a waiting list with no exercise (the control group), 28 did a concentric-focused exercise programme (muscles working as they shorten, such as pushing up from a squat), and 30 did an eccentric-focused exercise programme (muscles working as they lengthen, such as slowly lowering from a squat). The trial ran for four months and measured things like self-reported pain and stiffness, walking distance, time to rise from a chair or climb stairs, and leg strength. Not everyone finished — 18, 17, and 19 people completed the study in each group respectively. The reported data shows that on the main measure — a standard questionnaire called the WOMAC that scores pain, stiffness, and physical function (where a lower total score out of 96 means fewer difficulties) — all three groups had lower scores at four months compared to the start. The control group's total score went from about 27 to about 27 (roughly unchanged), while the concentric exercise group went from about 33 down to about 23, and the eccentric exercise group went from about 29 down to about 20. For the six-minute walk test, the reported distances at four months were approximately 1,640 feet for the control group, 3,496 feet for the concentric group, and 4,643 feet for the eccentric group. On leg strength tests (leg press, leg extension, and leg curl), the reported numbers shifted across all groups between the start and four months, though the pattern varied by group and exercise type. Chair-rise and stair-climb times were also recorded across groups, with the reported data showing small differences in seconds between the start and end of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01301950 · results posted 5 September 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total — 15 in each group — who were having a total knee replacement. One person in the TruMatch® group did not complete the study, so 15 people in the conventional group and 14 in the TruMatch® group finished. The trial was measuring how the two approaches to knee replacement surgery compared on a number of time-related factors, including how long the actual surgery took (from first cut to final closure), how long it took to set up and clean the operating room, and the costs involved. The reported data shows that the average surgery time (skin-to-skin, meaning from the first incision to wound closure) was 65.8 minutes for the conventional group and 67.3 minutes for the TruMatch® Personalized Solutions group. For operating room set-up time — measured from when the room was cleaned after the previous case to when the patient was fully draped and ready — the reported figures were 28.9 minutes (conventional) and 28.8 minutes (TruMatch®). The time taken to clean the operating room after surgery was reported as 10.1 minutes for the conventional group and 11.4 minutes for the TruMatch® group. For the two remaining secondary measures — costs associated with each surgical approach, and differences in operating room efficiency by hospital type and location — no numerical data was reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00733330 · results posted 15 August 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 84 people in total — 32 in the minimally invasive knee replacement group (using computer-assisted surgery, known as MiTKR CAS) and 52 in the conventional knee replacement group. The trial was designed to compare the two surgical approaches, mainly by looking at how precisely the replaced knee was aligned on full-leg X-rays. It also looked at secondary measures, including what proportion of procedures fell within an acceptable alignment range, how many achieved an optimal result by 6–12 weeks after surgery, and how participants' knees scored on a standard 100-point knee assessment scale (the American Knee Society Score, where a higher number indicates a better-functioning knee). The reported data shows that for the primary outcome — precision of leg alignment on X-rays — and for the secondary outcomes relating to alignment proportions and optimal implant positioning, no numerical results were submitted to ClinicalTrials.gov, so those figures cannot be described here. For the American Knee Society knee score, three sets of results were reported (likely representing different time points, though the specific time points were not labelled in the submitted data). In the first set, the MiTKR CAS group scored 54.1 points and the conventional group scored 45.3 points. In the second set, the scores were 63.8 and 66.3 points respectively. In the third set, the scores were 78.8 and 77.5 points respectively, out of a possible 100. It is worth noting that the time points for these knee scores were not clearly labelled in the data as submitted, so it is not possible to say with certainty when each measurement was taken. Across all three reported time points, the scores for both groups appear to have moved upward, though the reported data does not include any further detail about what drove those changes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01832155 · results posted 4 March 2014
According to the results reported on ClinicalTrials.gov, this trial involved 36 people in total — 18 in a yoga group and 18 in a wait-list control group (meaning the control group waited without receiving the yoga program during the study period). The trial was measuring several things over eight weeks, including joint-related symptoms such as pain, stiffness, and physical function in people with osteoarthritis, as well as sleep quality, quality of life, physical performance of the legs, and body mass index (a standard measure of body weight relative to height). The reported data shows that at the end of the eight weeks, participants in the yoga group scored an average of 31.0 on the WOMAC scale (a questionnaire measuring joint pain, stiffness, and physical difficulty, where higher numbers mean more difficulty, out of a possible 96), compared to 39.3 in the wait-list control group. For physical performance of the legs (scored out of 12, where higher is better), the yoga group scored 10.0 and the control group scored 9.0. For sleep quality (scored out of 21, where higher means worse sleep), the yoga group scored 5.0 and the control group scored 6.1. The reported data shows that quality-of-life scores across both groups were broadly similar at the end of the study, and average BMI figures were also close — 28.7 in the yoga group and 28.9 in the control group. A feasibility measure recorded that, on average, participants attended 6 yoga classes across the program. It is worth noting that this was a small study with 36 participants in total, and the results simply describe the numbers recorded at the end of the trial — they do not on their own tell us whether any differences between the groups were meaningful or due to chance. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01294696 · results posted 4 March 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,261 participants, all of whom had osteoarthritis of the knee. Of those, 1,187 completed the study and 74 did not. The trial was observational — meaning it watched and recorded what happened over time rather than testing one treatment against another. It was measuring how many participants reported adequate or inadequate pain control, as well as how many reported adequate relief from joint stiffness and limitations in physical movement, at various points over 12 months. Pain was rated by participants themselves on a numbered scale from 0 (no pain) to 10 (worst pain imaginable), using a standard questionnaire called the Brief Pain Inventory (BPI). A score of 4 or below on that scale was counted as "adequate" pain control; anything above 4 was counted as "inadequate." The reported data shows that at the start of the trial, 46.2% of participants were already reporting adequate pain control, while 53.8% were reporting inadequate pain control. At the 12-month mark, those figures were very similar — 47.3% reporting adequate pain control and 52.7% reporting inadequate pain control. For the secondary measures — joint stiffness and physical function, assessed using a separate questionnaire called the WOMAC — the reported data shows that 43.4% of participants reported adequate relief at the start of the trial. That figure was 44.8% at one month, 44.7% at three months, and 45.3% at six months. Results for this measure at 12 months were not reported in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01132378 · results posted 19 November 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 participants who underwent knee surgery using a technique called the "mini-midvastus incision" approach. All 40 participants completed the trial with none dropping out. The trial was measuring outcomes related to knee function and pain, as well as quadriceps (thigh muscle) strength following the procedure. The reported data shows that the primary outcome — the Knee Society Score, a scale from 0 to 100 where higher numbers indicate better function and less pain — was measured across two groups: one that received a "medial parapatellar" surgical approach (scored 98.70 out of 100) and one that received a "mini-midvastus" surgical approach (scored 99.03 out of 100). Both groups recorded scores near the top of the scale. It is worth noting that while two groups appear in the outcome results, the participant breakdown only described a single group in the enrolment data, so the exact number of participants in each group was not separately reported in the data provided. For the secondary outcome — quadriceps (thigh muscle) strength — no numerical results were reported in the data submitted to ClinicalTrials.gov, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01235715 · results posted 29 October 2013
According to the results reported on ClinicalTrials.gov, this trial looked at a product called Evicel — a type of surgical sealant — used during knee replacement surgery. A total of 200 people took part: 98 received Evicel and 102 did not. All 98 in the Evicel group completed the study, while 100 of the 102 in the comparison group completed it (2 did not finish, though the reason was not reported in the data). The trial measured blood-related changes immediately after surgery, as well as knee movement and pain levels a few days later. The reported data shows that for the main outcomes, both groups experienced a drop in haemoglobin (a protein in red blood cells that carries oxygen) on the day of surgery — a fall of about 1.55 units in the Evicel group and 1.46 units in the no-Evicel group. By the following day, haemoglobin had dropped further in both groups, by about 2.61 units with Evicel and 2.48 units without. A related measure called haematocrit (the proportion of red blood cells in the blood) also fell on the day of surgery — by about 4.64 percentage points in the Evicel group and 4.22 percentage points in the no-Evicel group. For the secondary outcomes, a measure of how quickly blood clots (called INR) increased by 0.36 in the Evicel group and 0.31 in the no-Evicel group by day two. On day three, knee movement was reported at about 112 degrees in the Evicel group and 114 degrees in the no-Evicel group. Self-reported pain scores on a 0–10 scale (where 0 means no pain and 10 means the worst possible pain) were 4.3 in the Evicel group and 3.9 in the no-Evicel group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01612702 · results posted 21 May 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 291 people who were having total knee replacement surgery — 146 in the dexamethasone group (a steroid medicine given around the time of surgery) and 145 in a control group who did not receive it. The trial was measuring nausea and vomiting after surgery as its main focus, and also looked at pain levels and wound complications as secondary measurements. Around 135 and 134 people in each group respectively completed the study, with 11 people in each group not finishing. The reported data shows that, for the main outcome, 24% of participants in the dexamethasone group experienced nausea or vomiting after surgery, compared with 40% in the control group. For pain levels — measured on a scale from 0 (no pain) to 10 (worst imaginable pain), recalling the worst pain felt between 6 and 24 hours after surgery — the dexamethasone group reported an average score of 2.4, while the control group reported an average of 4.0. For wound complications (such as signs of infection within 30 days of surgery), the reported data shows that 1 participant in each group experienced a complication. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01081886 · results posted 3 January 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people in total — 11 in the PlasmaBlade group and 13 in the Standard of Care group. The trial was comparing two surgical tools used during knee surgery, looking at things like post-operative pain, how long the operation took, how much blood was lost, scarring, and a knee function score called the Knee Society Score. Pain was measured using the Wong-Baker FACES scale, which runs from 0 (no pain) to 10 (worst possible pain), with each participant's scores tracked over 10 days. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — neither the primary measure (post-operative pain) nor the secondary measures (operative time, blood loss, scarring, and knee function score). The data was simply not reported for either group. It is also worth noting that the records indicate zero participants in both groups were recorded as having "completed" the study, though the reason for this was not explained in the submitted data. Because no outcome numbers were provided in the submission, it is not possible to describe what the measurements showed for either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT01094886 · results posted 27 February 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 53 people who all received the blood-thinning medication rivaroxaban. Of those, 46 people completed the study and 7 did not finish. The trial was measuring how rivaroxaban affected two markers in the blood — "Anti-Factor Xa" (a measure of how much the drug was blocking a particular clotting protein) and "prothrombin time" (how long the blood takes to begin clotting) — by taking blood samples at seven time points over a 24-hour period on both the first day (Day 1) and the third day (Day 3) of taking the medication. The reported data shows that for the primary outcomes, the highest recorded Anti-Factor Xa level was 1.66 IU/ml on Day 1 and 1.83 IU/ml on Day 3. The longest recorded prothrombin time (clotting time) was 21.57 seconds on Day 1 and 20.51 seconds on Day 3. For the secondary outcomes, the overall exposure to Anti-Factor Xa across the full 24-hour period (a measure called "area under the curve," which reflects the total amount of drug effect over time) was reported as 21.35 on Day 1 and 20.74 on Day 3. The equivalent overall measure for prothrombin time was 420.46 second-hours on Day 1 and 391.37 second-hours on Day 3. The reported data does not include information about statistical comparisons between the Day 1 and Day 3 values, so it is not possible from these numbers alone to draw conclusions about the meaning of any differences observed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00588861 · results posted 26 January 2012
According to the results reported on ClinicalTrials.gov, this trial involved people who received a hip replacement using an implant called the "Answer Stem," held in place with one of two types of bone cement — Simplex cement (202 people enrolled, 107 completing the pre-operative stage) or Palacos cement (200 people enrolled, 114 completing the pre-operative stage). The trial tracked participants over a long period — up to 10 years — with check-ins at 6 months, 1 year, 2 years, 4 years, 6 years, 8 years, and 10 years. The main thing being measured was a scoring system called the Harris Hip Score, which rates hip function on a scale from 0 (poorest) to 100 (best), with scores of 90–100 rated "Excellent," 80–89 "Good," 70–79 "Fair," and below 70 "Poor." The reported data shows that, unfortunately, no numbers were submitted for the primary outcome — the overall Harris Hip Score — so those results cannot be described here. For the secondary outcome, which measured the pain portion of the Harris Hip Score alone (scored 0–44, where 44 means no pain and 0 means totally disabled), figures were reported at several time points. Before the operation, the Simplex cement group averaged 15.89 and the Palacos cement group averaged 14.74 — both in the "Moderate" pain range. At 6 months post-surgery, averages rose to 39.78 and 36.25 respectively, moving into the "Slight/Occasional" pain range. At 1 year, scores were 37.89 and 37.76; at 2 years, 36.93 and 34.59; at 4 years, 38.38 and 41.27; and at the final reported time point (6 years), scores were 44.00 and 42.00. Participant numbers completing each follow-up visit were notably low at later time points, and the data for 8-year and 10-year visits was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00131352 · results posted 19 January 2012
According to the results reported on ClinicalTrials.gov, this trial involved people with knee osteoarthritis and compared two treatments given by injection into the knee: Synvisc (a gel-like substance) and a saline (salt water) control. In the initial 26-week treatment period, 123 people started in the Synvisc group and 130 in the saline group, with 114 and 118 respectively completing that period. A second treatment period followed, in which 160 participants received Synvisc (the saline group did not continue into this phase). The trial's main focus was measuring changes in knee pain using a standard questionnaire called the WOMAC, where scores run from 0 (no pain) to 4 (extreme pain). The reported data shows that, for the primary measure — the average change in knee pain across the full 26-week period — the Synvisc group's pain score decreased by 0.84 points from their starting score, while the saline group's score decreased by 0.69 points (both reductions measured on the 0–4 scale). At week 26 specifically, the reported pain score reductions were 0.76 points for Synvisc and 0.58 points for saline. For physical function (also scored 0–4, where higher means more difficulty), the reported change across the 26 weeks was a decrease of 0.66 for Synvisc and 0.63 for saline; at week 26 alone, the decreases were 0.59 and 0.48 respectively. The reported data also shows how participants rated their walking pain and their overall knee condition at week 26. For walking pain, in the Synvisc group 17 reported no pain, 45 mild, 41 moderate, 11 severe, and 1 extreme; in the saline group the numbers were 13, 39, 42, 19, and 4. For the overall knee condition rating, in the Synvisc group 9 rated it "very well," 33 "well," 50 "fair," 21 "poor," and 2 "very poor"; in the saline group the figures were 2, 27, 54, 31, and 3. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00982280 · results posted 14 December 2011
According to the results reported on ClinicalTrials.gov, this trial involved 82 people who took part in an initial observation period, during which they continued their existing pain medication. Of those, 63 moved on to a dose-finding stage with a pain medicine called tapentadol PR (a slow-release tablet), and 55 then entered a maintenance stage. The trial was looking at how participants rated their pain on tapentadol PR compared to their previous pain medicine, as well as measuring changes in pain levels and knee-related symptoms such as stiffness and difficulty moving. The reported data shows that the main thing being measured — called the "responder rate" — found that 50 out of the participants who completed the treatment were classed as "responders," meaning their pain rating stayed the same or was lower after six weeks on tapentadol PR compared to their previous treatment. Before starting tapentadol PR, the average self-reported pain score (on a scale of 0 to 10, where 10 is the worst imaginable pain) was 4.7. The reported data shows an average change of minus 2.2 points after 6 weeks and minus 2.7 points after 12 weeks, meaning scores were lower on average at both time points compared to the starting score. A separate questionnaire measuring knee pain, stiffness, and physical function (scored 0–96, where higher means more symptoms) started at an average of 54.2, and the reported data shows an average change of minus 24.5 points at the six-week mark, indicating scores were lower on average compared to the starting point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00665431 · results posted 6 December 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 610 people in total across three groups: 243 people took a medication called PN 400 (also known as Vimovo, a combination of naproxen and a stomach-protecting medicine) twice a day; 245 people took Celebrex (celecoxib) 200 mg once a day; and 122 people took a placebo (a dummy tablet with no active ingredient) twice a day. The trial was measuring changes in arthritis-related pain, physical function, and overall wellbeing in people with osteoarthritis of the knee or hip, using standard questionnaires over 12 weeks. By the end of the study, 203, 188, and 98 people in each group respectively had completed the trial. The reported data shows results from a pain and function questionnaire called WOMAC, where scores run from 0 (no pain/difficulty) to 100, and a lower score means improvement. At 12 weeks, the PN 400 group's pain score had dropped by an average of 44.1 points, the Celebrex group's by 43.6 points, and the placebo group's by 37.3 points. For physical function at 12 weeks, the reported drops were 38.7, 37.7, and 30.9 points respectively. On a separate "how are you doing overall" question (scored 0–100, where higher is better), the reported average improvements from the starting point were 27.7, 26.4, and 22.4 points for the three groups in the same order. The reported data also shows results from a secondary measure of how much pain interfered with daily life (scored 0–70, where 0 means no interference). By Day 7, the PN 400 group's interference score had dropped by an average of 18.8 points, the Celebrex group's by 16.6 points, and the placebo group's by 11.6 points. At the 6-week mark, pain scores had dropped by 44.3, 39.6, and 33.9 points, and function scores by 38.5, 34.6, and 29.0 points, for the three groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00790790 · results posted 5 October 2011
According to the results reported on ClinicalTrials.gov, this trial (NCT00790790) tested an investigational drug called LY545694 at two doses (49 mg and 105 mg) compared to a placebo (inactive treatment) in people with chronic pain. A total of 147 people entered the main treatment phase — 49 on placebo, 50 on the 49 mg dose, and 48 on the 105 mg dose. By the end of that phase, 37 people in the placebo group, 32 in the 49 mg group, and 27 in the 105 mg group had completed it. The main thing being measured was how much participants' average daily pain score changed over five weeks, using an 11-point scale where 0 means no pain and 10 means the worst possible pain. The reported data shows that after five weeks, all three groups reported lower average pain scores than when they started. The placebo group's score dropped by about 2.05 points, the 49 mg group's by about 2.10 points, and the 105 mg group's by about 2.09 points. The secondary measurements told a similar story — changes in night pain, worst daily pain, how severe doctors rated the condition, and how much pain interfered with daily life were all broadly similar across the three groups. For example, night pain scores dropped by roughly 2.22 points in the placebo group, 2.13 in the 49 mg group, and 2.19 in the 105 mg group. When looking at how many people achieved at least a 30% reduction in their average pain score, the reported numbers were 17 in the placebo group, 17 in the 49 mg group, and 21 in the 105 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00295490 · results posted 9 September 2011
According to the results reported on ClinicalTrials.gov, this trial looked at three different daily doses of a herbal supplement called Devil's Claw (240 mg, 960 mg, and 1,920 mg) compared to a placebo (a dummy treatment with no active ingredient) in people with osteoarthritis. A total of 67 people started the trial across the four groups, and 53 completed it. Participants were assessed at the start of the trial, at 8 weeks, and again at 16 weeks using several questionnaires. These included a well-known osteoarthritis questionnaire (called WOMAC) that measures pain, stiffness, and physical function, a general quality-of-life survey (SF-36), and a question asking participants to rate their own overall wellbeing. The reported data shows that, unfortunately, no actual numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — including the primary measure (the overall WOMAC score) or any of the secondary measures (pain, stiffness, disability, quality of life, and patient self-assessment). While the trial clearly defined what it intended to measure and how those scores would be calculated, the specific numbers reflecting what happened between the start and end of treatment were not reported in the data. Because no results figures were provided in the ClinicalTrials.gov record, it is not possible to describe what the scores showed for any of the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00562627 · results posted 8 August 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 102 people in total — 34 in each of three groups — who were having knee replacement surgery. One person in each group did not complete the study, leaving 33 completers per group. The trial compared three different approaches to managing pain after the operation: two types of local anaesthetic injected either into the bloodstream (LIA IV) or directly into the joint (LIA IA), and a third method called an epidural (where pain relief is delivered into the space around the spinal cord). The main thing being measured was pain at rest, using a simple 0–100 scale where 0 means no pain and 100 means the worst possible pain. The reported data shows that, on the primary measure of resting pain, the LIA IA group scored an average of 12 out of 100, the LIA IV group scored 18 out of 100, and the epidural group scored 30 out of 100. For additional (secondary) measures, the reported data shows that the amount of morphine used in the first 48 hours after surgery was 49 mg in the LIA IA group, 54 mg in the epidural group, and 77 mg in the LIA IV group. Regarding how long it took before patients were considered ready to go home, the reported figures were 3.5 days for the LIA IA group, 4 days for the LIA IV group, and 5.5 days for the epidural group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT01135524 · results posted 23 September 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 196 participants in what was described as an extension phase — meaning it was a follow-on study for people who had already taken part in an earlier trial. The study was measuring safety and tolerability, which in plain terms means it was tracking any unwanted health events (called adverse events) that participants experienced, alongside checks such as blood tests, physical examinations, and measurements like blood pressure and heart rate. The reported data shows the primary outcome measured how many participants experienced adverse events. Three separate figures were listed for the same Extension Phase group: 1 participant, 14 participants, and 93 participants. Unfortunately, the data as submitted does not include labels clearly explaining what each of these three numbers specifically refers to (for example, whether they represent different levels of seriousness of adverse events), so it is not possible to describe them in more detail without risking misrepresentation. It is also worth noting that the data shows zero participants were recorded as having completed the study, with all 196 listed as "not completed," though no explanation for this was provided in the submitted results. Because the labels for these figures were not fully reported, the exact meaning of each number cannot be stated with confidence here. If you are looking for more detail about what these figures represent, the full study record and any associated publications would be the place to look, and your doctor would be best placed to help you interpret them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00531427 · results posted 21 September 2010
According to the results reported on ClinicalTrials.gov, this trial involved 567 people in total — 282 in the group receiving a buprenorphine patch (at either a 10 or 20 microgram dose, referred to as BTDS) and 285 in a placebo group (a patch with no active medicine). The trial was measuring knee pain in people with osteoarthritis over a 12-week double-blind period, meaning neither the participants nor the researchers knew who was receiving which patch during that time. The main thing being tracked was how participants rated their average knee pain over the previous 24 hours, using a scale from 0 (no pain) to 10 (worst pain imaginable). The reported data shows that at the start of the double-blind phase, both groups rated their pain similarly — around 7.1 out of 10 for the BTDS group and 7.1 out of 10 for the placebo group. By week 12, the BTDS group reported an average pain score of 2.63, while the placebo group reported 2.74. The reported data also shows a "change from baseline" (the difference between the starting score and the week 12 score) of approximately 3.82 points for the BTDS group and 4.22 points for the placebo group. On the secondary measures, the reported data shows that participants in the BTDS group used an average of 0.70 additional pain-relief tablets per day, compared to 0.74 in the placebo group. For sleep disturbance — measured on a scale where higher scores mean more disrupted sleep — the BTDS group scored around 27 at weeks 4, 8, and 12, while the placebo group scored around 35 at those same time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00487435 · results posted 23 July 2010
According to the results reported on ClinicalTrials.gov, this trial involved 1,154 people who took a slow-release form of a painkiller called tapentadol (also known as CG5503 ER). The trial ran for up to 52 weeks and was designed to track two things: how many participants experienced unwanted health events (called "treatment-emergent adverse events") while taking the medication, and whether participants' average pain levels changed over time. Of the 1,154 people who started, 669 completed the trial, and 485 did not finish. The reported data shows that the main thing this trial was measuring was unwanted health events — not whether the medication reduced pain. Out of 1,154 participants, 907 reported at least one unwanted health event that started or got worse after beginning the study medication (up to three days after stopping it). As a secondary measure, participants rated their average pain over the previous 24 hours on a scale of 0 ("no pain") to 10 ("worst pain imaginable"). The reported data shows an average change of −0.26 points from the starting score to the 52-week mark, meaning the average score was very slightly lower at the end of the study period compared to the beginning. It is important to note that this trial was primarily set up to track unwanted health events rather than to test how well the medication reduced pain, so the pain score result is a secondary finding only. The reported data shows numbers for the group as a whole and does not tell us how any individual person responded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00421928 · results posted 23 April 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,023 adults across three groups: 344 received tapentadol (also called CG5503), 342 received oxycodone, and 337 received a placebo (a dummy treatment with no active ingredient). The trial ran for 12 weeks and was primarily measuring changes in knee pain intensity, using an 11-point scale where 0 meant "no pain" and 10 meant "pain as bad as you can imagine." Not everyone finished the trial — 181 tapentadol participants, 118 oxycodone participants, and 203 placebo participants completed it, meaning a notable number of people in each group withdrew before the end. The reported data shows that, on average, pain scores dropped from where they started across all three groups by the end of 12 weeks. The tapentadol group's average pain score fell by 3.0 points, the oxycodone group's fell by 2.6 points, and the placebo group's fell by 2.2 points. For the secondary measures, the reported data shows similar patterns. On a questionnaire about knee pain, stiffness, and physical function (called WOMAC, scored 0–4), scores fell by 1.2 points in the tapentadol group, 1.1 in the oxycodone group, and 0.9 in the placebo group. When participants were asked to rate their overall impression of change, 51.1% of the tapentadol group, 37.7% of the oxycodone group, and 32.4% of the placebo group reported feeling "much improved" or "very much improved." On a general health quality-of-life scale (EQ-5D, where 1.00 represents full health), scores increased by 0.6 in the tapentadol group and 0.5 in both the oxycodone and placebo groups. For the time-to-sleep measure and the median time to stopping treatment due to lack of effect, the data was either not reported or not available in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
-
NCT00485472 · results posted 22 September 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 149 people in total — 73 in the lacosamide group and 76 in the placebo group (a placebo is a dummy treatment with no active ingredient). The trial was looking at whether lacosamide, a medicine more commonly used for epilepsy, could reduce pain and improve daily functioning in people with osteoarthritis of the knee. Participants were assessed using a standard questionnaire called the WOMAC, which uses a scale of 0–100 to score pain, stiffness, and difficulty with daily activities (higher numbers mean more pain or difficulty). The main measurement was how much pain scores changed after an 8-week treatment period. The reported data shows that, for the primary measure of pain, both groups reported lower pain scores by the end of the study. The lacosamide group's average pain score fell by about 24.9 points, while the placebo group's fell by about 28.5 points — meaning the placebo group reported a slightly larger reduction in pain. For the secondary measures, the reported data shows similar patterns: physical function scores dropped by around 17.1 points (lacosamide) versus 23.3 points (placebo); stiffness scores dropped by around 18.9 points (lacosamide) versus 23.4 points (placebo); and the combined total WOMAC score fell by around 60.9 points (lacosamide) versus 75.2 points (placebo). In each case, the placebo group reported a greater reduction than the lacosamide group. The reported data also shows that, when participants were asked about their overall impression of change, and when a standard response criteria was applied, 38 people in the lacosamide group and 52 people in the placebo group were recorded as meeting the threshold for meaningful improvement. The full breakdown of individual patient global impression ratings was included in the submitted data, though a complete labelled category-by-category summary was not provided in the data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
-
NCT00361504 · results posted 4 September 2009
According to the results reported on ClinicalTrials.gov, this trial compared two pain medicines — tapentadol (also called CG5503) and oxycodone. A total of 894 people were assigned to the tapentadol group and 223 to the oxycodone group, making 1,117 participants in all. The trial ran for up to 52 weeks and was primarily focused on tracking any unwanted or unexpected health events (called "treatment-emergent adverse events") that participants experienced while taking the medicines. It also measured changes in how participants rated their average pain levels over time. The reported data shows that, when it came to the primary focus of the trial — tracking unwanted health events — 766 out of 894 participants (about 86%) in the tapentadol group and 202 out of 223 participants (about 91%) in the oxycodone group reported at least one such event during the study period. For the secondary measure, pain was rated on a scale of 0 (no pain) to 10 (worst pain imaginable). The reported data shows that, at the 52-week mark, participants in the tapentadol group reported an average decrease of 3.22 points from their starting score, while those in the oxycodone group reported an average decrease of 3.14 points. It is also worth noting that a large proportion of participants did not complete the full trial — 481 in the tapentadol group and 145 in the oxycodone group — though the reasons for this were not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
See the full Osteoarthritis page · What changed recently
Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.