Preventing Injured Knees From osteoArthritis: Severity Outcomes
Recruiting
Phase 2
Interventional Study
Osteoarthritis, Knee
Post-traumatic Osteoarthritis
ACL Tear
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 45
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 512 (estimated)
- Sponsor
- Brigham and Women's Hospital · Other
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About This Trial
This study is being done to find out if metformin is effective at reducing pain by delaying the onset of post-traumatic osteoarthritis (PTOA) after anterior cruciate ligament (ACL) reconstruction. This research study will compare metformin to placebo. The placebo tablet looks exactly like metformin, but contains no metformin. Placebos are used in research studies to see if the results are due to t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 25-45 or Age 18-24 with preoperative KOOS Pain \<80 (0-100, 100 best) recorded at least 14 days after the day of ACL injury
2. Plan to undergo ACL reconstruction within 12 months of injury
Exclusion Criteria:
1. Inflammatory arthritis
2. Pregnancy and/or lactation, or p…
Contacts