Actively Recruiting
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Led by Brigham and Women's Hospital · Updated on 2025-04-29
512
Participants Needed
9
Research Sites
290 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
A
Arthritis Foundation
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 25-45 years, or age 18-24 years with preoperative KOOS Pain score less than 80 recorded at least 14 days after ACL injury
- Plan to undergo ACL reconstruction within 12 months of injury
You will not qualify if you...
- Inflammatory arthritis
- Pregnancy, 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 kidney problems
- Previous ACL tear on the injured knee, with or without reconstruction
- ACL tear on the opposite knee within the past 12 months
- Applying for or receiving Workers' Compensation for the knee injury
- Joint space narrowing and definite osteophytes on weightbearing X-rays of the injured knee
- Tibial plateau fracture on the injured knee
- Avulsion fracture of injured knee requiring surgery
- Injury to other knee ligaments requiring surgical repair
- Contraindication to MRI
- Unable to speak and understand English
- Cognitive impairment or unable to give informed consent
- Surgery scheduled less than 14 days from screening
- Injury date more than 6 months before screening
- Any condition that may affect safety or study data quality as judged by the surgeon
- Plan to use allograft at time of consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
3
University of Kentucky
Lexington, Kentucky, United States, 40504
Actively Recruiting
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
6
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
7
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 25599
Actively Recruiting
8
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
9
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
F
Faith Selzer, PhD
CONTACT
D
Daniel J Betensky, AB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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