Osteoarthritis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are between 22 and 65 years old at the time of screening
• People who have pain at the front of the knee caused by cartilage breakdown behind the kneecap, confirmed by MRI to be at a moderate-to-severe level (Modified Outerbridge score of 3 or higher)
• People with a Body Mass Index (BMI) of 35 or below
• People who weigh less than 300 pounds
• People whose knee function score on a standard questionnaire (called the Anterior Knee Pain Score) is 70 or below out of 100, indicating meaningful difficulty
• People whose pain level on a standard pain scale (Visual Analog Score) is 40 or above out of 100, indicating a notable level of pain
• People who have already tried at least 6 months of non-surgical treatments — such as rest, bracing, physical therapy, targeted exercise, anti-inflammatory medications, or activity changes — without enough improvement

Who may not be able to join:

• People whose cartilage breakdown behind the kneecap is rated at a mild level (Modified Outerbridge score of 2 or lower)
• People who have significant pain or problems in the opposite knee that affect daily activities, stair climbing, or that require a walking aid
• People who have a history of their kneecap slipping out of place or being unstable
• People whose kneecap sits too high or too low in its groove (a condition called patella alta or patella baja)
• People with a known measurement between two specific bony points in the knee (called TT-TG distance) of more than 20mm, which relates to kneecap alignment (confirm with trial site)
• People who would need a cartilage grafting, cartilage transplantation, or bone marrow stimulation procedure at the same time as this trial procedure
• People who have previously had a repair of a torn patellar tendon (the tendon connecting the kneecap to the shinbone)
• People who have previously had a tibial tubercle realignment surgery or a full or partial knee replacement in the study knee
• People who have had joint-altering surgery in the study knee — such as ligament reconstruction, meniscus repair, cartilage transplantation, or microfracture — within the 6 months before the planned trial procedure
• People who have had arthroscopic knee surgery for joint washout, meniscus removal, cartilage cleaning, or loose body removal in the study knee within 3 months before the planned trial procedure
• People with a current infection, bone infection, or a history of a joint infection in any joint
• People who have rheumatoid arthritis, another form of inflammatory joint disease, or an autoimmune condition
• People with a history of bone tissue death due to loss of blood supply (avascular necrosis) in any bone
• People with a history of significant patellar tendon pain or a tear within the body of that tendon
• People whose knee ligaments or tendons are not stable enough to support the trial device being studied (confirm with trial site)
• People with significant ligament injury or meniscus tearing in the study knee (confirm with trial site)
• People who have significant pain or problems with the main (thigh-to-shin) part of the study knee joint that affect daily activities, stair climbing, or that require a walking aid
• People whose MRI or other imaging shows severe cartilage damage (Modified Outerbridge Grade 4) in the thigh-to-shin part of the study knee that may be the likely cause of their symptoms

Important: Always verify eligibility with the trial site directly before applying.