Preventing Injured Knees From osteoArthritis: Severity Outcomes
Eligible age
18–45 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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 the study drug or due to other reasons. Metformin is approved by the U.S. Food and Drug Administration (FDA) to treat type II diabetes. Notably, it also has anti-inflammatory effects, suggesting it could benefit people who have an ACL injury and are undergoing ACL reconstruction.
Sponsor: Brigham and Women's Hospital
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 1. Inflammatory arthritis
- ✕ 2. Pregnancy and/or lactation, or plans to become pregnant in the next 12 months
- ✕ 3. Known contraindication to metformin
- ✕ 4. Current use of metformin or topiramate
- ✕ 5. Diabetes mellitus or diabetic ketoacidosis
- ✕ 6. Acute or chronic renal insufficiency
- ✕ 7. History of prior ACL tear on the index knee, with or without reconstruction
- ✕ 8. History of ACL tear on the contralateral knee within the past 12 months
Where it's recruiting
Atlanta
Iowa City
Lexington
Boston
Omaha
New York
Chapel Hill
Cleveland · Columbus
Source: ClinicalTrials.gov · NCT06096259 · last updated 2025-04-29