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 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.
Eligibility criteria
Qualifiers
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
Plan to undergo ACL reconstruction within 12 months of injury
Disqualifiers
Inflammatory arthritis
Pregnancy and/or lactation, or plans to become pregnant in the next 12 months
Known contraindication to metformin
Current use of metformin or topiramate
Trial design
Treatments tested in this trial
- Metformin
- Placebo
Treatment groups
Sponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
Arthritis Foundation
Collaborator