Preventing Injured Knees From osteoArthritis: Severity Outcomes
Recruiting · NCT06096259 · Interventional (participants receive a specific treatment) · Lead sponsor: Brigham and Women's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
- Diabetes mellitus or diabetic ketoacidosis
- Acute or chronic renal insufficiency
- History of prior ACL tear on the index knee, with or without reconstruction
- History of ACL tear on the contralateral knee within the past 12 months
- Applying for or receiving Workers' Compensation for their knee injury
- Joint space narrowing AND definite osteophyte(s) on weightbearing radiograph on index knee
- Tibial plateau fracture on index knee
- Concomitant avulsion fracture of index knee that will be treated surgically
- Concomitant posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament injury on index knee requiring surgical repair/reconstruction
- Contraindication to MRI
- Unable to speak and understand English
- Diagnosis of cognitive impairment or otherwise unable to provide informed consent
- Insufficient time for recruitment and drug titration: Surgery scheduled for \<14 days from the time of screening
- Date of injury more than 6-months ago, relative to date of screening
- 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
- Plan for allograft at time of consent
Where it is running
9 locations listed across 8 US states.
- Emory University - Atlanta, Georgia, United States
- University of Iowa Hospitals and Clinics - Iowa City, Iowa, United States
- University of Kentucky - Lexington, Kentucky, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- Hospital for Special Surgery - New York, New York, United States
- The University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- The Ohio State University - Columbus, Ohio, United States