Metformin for Preventing Osteoarthritis After ACL Injury
This study is investigating if metformin, a common diabetes medication, can help reduce pain and delay the development of post-traumatic osteoarthritis (PTOA) in your knee after an anterior cruciate ligament (ACL) injury and reconstruction surgery. You might be able to join if you are between 18 and 45 years old and are planning to have ACL reconstruction within 12 months of your injury. The study will compare metformin to a placebo (an inactive pill that looks the same) to see if metformin is effective. Researchers will measure your knee pain and look at changes in your knee cartilage to determine if metformin is successful in preventing or slowing down PTOA. The study aims to enroll 512 participants, but its current status is unclear.
- Study design
- This interventional study will involve 512 participants and compare metformin to a placebo. Participants will receive either metformin or a matching placebo tablet.
- What's involved
- Participants will start with one 500mg pill once a day, with the dose increasing every 5 days up to a maximum of 1500mg daily, as tolerated.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pain will be measured at an average of 12 and 24 months, and your knee cartilage will be assessed at 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Preventing Injured Knees From osteoArthritis: Severity Outcomes
At a glance
Conditions
Where it's being run
9 sites across 8 statesStudy leadership
- Morgan H Jones, MD, MPH · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
- Cale A Jacobs, PhD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
Who to contact
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What this trial measures
- KOOS Pain ScoreAverage of 12 and 24 months
To determine whether metformin leads to reduced pain as measured by the KOOS pain subscale compared to placebo between 12 and 24 months postoperatively. Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS pain subscale contains 9 items and is scored on a 0-100 scale, 100 being best.
- Modified MOAKS Cartilage Score24 months
To determine whether metformin leads to reduced structural degeneration at 24 months postoperatively compared to placebo. The MOAKS score (MRI Osteoarthritis Knee Score) is a semi-quantitative whole joint assessment of knee osteoarthritis with very good to excellent reliability used to score knee osteoarthritis. In MOAKS the knee is divided into 14 articular subregions for scoring articular cartilage and bone marrow lesions (BMLs) and in addition the subspinous region is added for BML scoring. For each region, the following features are assessed independently: 1. bone marrow lesions and cysts (score: 0-3, 3 worst) 2. articular cartilage loss (score: 0-3, 3 worst) 3. osteophytes (score: 0-3, 3 worst) 4. synovitis and effusion (score: 0-3, 3 worst) 5. meniscus extrusion and morphology (score: 0-3, 3 worst) 6. ligaments/tendon (0/1, 0=normal, 1=abnormal) 7. periarticular features (0/1, 0=absent, 1=present)