Preventing Injured Knees From osteoArthritis: Severity Outcomes

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBrigham and Women's Hospital

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

512 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Brigham and Women's Hospital

Lead sponsor

Arthritis Foundation

Collaborator