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Preventing Injured Knees From osteoArthritis: Severity Outcomes

RecruitingPhase 2Ages 18 Years - 45 YearsAllBrigham and Women's Hospital
NCT06096259 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 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 9. Applying for or receiving Workers' Compensation for their knee injury 10. Joint space narrowing AND definite osteophyte(s) on weightbearing radiograph on index knee 11. Tibial plateau fracture on index knee 12. Concomitant avulsion fracture of index knee that will be treated surgically 13. Concomitant posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament injury on index knee requiring surgical repair/reconstruction 14. Contraindication to MRI 15. Unable to speak and understand English 16. Diagnosis of cognitive impairment or otherwise unable to provide informed consent 17. Insufficient time for recruitment and drug titration: Surgery scheduled for \<14 days from the time of screening 18. Date of injury more than 6-months ago, relative to date of screening 19. Presence of a condition or abnormality that in the opinion of the surgeon investigator would compromise the safety of the patient or the quality of the data 20. Plan for allograft at time of consent
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What it tests

  • Metformin
  • Placebo
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Where

9 sites
Emory University
Atlanta, United States
University of Iowa Hospitals and Clinics
Iowa City, United States
University of Kentucky
Lexington, United States
Brigham and Women's Hospital
Boston, United States
University of Nebraska Medical Center
Omaha, United States
Hospital for Special Surgery
New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, United States
Cleveland Clinic
Cleveland, United States

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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