Osteoarthritis Trial, Recruiting NCT05596591 Sponsor: Kessler Foundation Condition: Osteoarthritis
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Osteoarthritis Trial, Recruiting

NCT05596591
Recruiting Not Applicable

Who may be able to join

AI generated eligibility 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

Who might be able to join this trial:

  • People between 30 and 80 years old (inclusive)
  • People whose knee X-ray shows a level of arthritis graded 2 to 4 on a standard scale called the Kellgren-Lawrence scale
  • People who have a specific type of bone injury called a bone marrow lesion (BML), visible on an MRI scan, in a weight-bearing area of the knee (the inner or outer parts of the thigh bone or shin bone where they meet the knee)
  • People who have had knee pain for more than 2 months
  • People whose knee pain, in the week before the screening visit, rated at least 4 out of 10 on a pain scale (where 0 means no pain and 10 means the worst pain imaginable)
  • People whose knee pain is located in the same part of the knee where the bone marrow lesion is found
  • People who have already tried at least 4 weeks of basic treatments without enough relief, such as rest, pain relief medication, or reducing weight on the knee (with or without a walking aid)

Who may not be able to join:

  • People whose bone marrow lesion was caused by a physical injury or trauma
  • People whose main cause of knee pain and loss of function comes from a condition other than a bone marrow lesion, based on their medical history and a clinical assessment
  • People who have bone marrow lesions in both knees
  • People with systemic autoimmune diseases, such as lupus or rheumatoid arthritis
  • People currently taking steroid medications (glucocorticoids) for any other health condition
  • People who have previously had certain treatments for bone marrow lesions, including a procedure called subchondroplasty in the affected knee, or injections of biological substances (such as platelet-rich plasma, bone marrow concentrate, or fat-derived treatments) into the knee joint or bone within the past 6 months
  • People who have previously taken bone-strengthening medications called bisphosphonates, unless enough time has passed since stopping them — the required gap depends on how long the medication was taken and how it was given (confirm with trial site for specific timeframes)
  • People who have had a steroid injection into the knee joint within the past 3 months
  • People who have had knee surgery within the past 6 months
  • People with tumours
  • People with an active infection or fracture in the same leg as the affected knee
  • People who are pregnant
  • People who have medical reasons they cannot receive a treatment called focused extracorporeal shockwave therapy (f-ESWT), such as serious blood clotting disorders or a malignant tumour in the treatment area
  • People who are unable to have an MRI scan, including those with certain metal implants in their body (such as a pacemaker, metal heart valve, cochlear implant, brain stimulator, or metal fragments near the eyes), those with claustrophobia, or those whose doctor has advised that MRI scanning is not medically safe for them

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 9733243584

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Kessler Foundation
Registry
ClinicalTrials.gov
Start date
13 October 2022
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in knee pain numerical rating scale scores

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov