Metformin for Pain Relief After ACL Injury
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Recruiting
Phase 2
Interventional Study
Osteoarthritis, Knee
Post-traumatic Osteoarthritis
ACL Tear
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 45
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 512 (estimated)
- Sponsor
- Brigham and Women's Hospital · Other
Who this trial is looking for
This trial is looking for people aged 18-45 who have had an ACL injury and are planning to have surgery. Participants will take either metformin or a placebo that looks like metformin to see if it helps reduce pain related to post-traumatic osteoarthritis.
Are You a Good Fit for This Trial?
You may be able to join if
- I am aged 25-45 or 18-24 with specific pain levels after my injury.
- I plan to undergo ACL reconstruction within 12 months of my injury.
You may not be able to join if
- I have inflammatory arthritis.
- I am pregnant, breastfeeding, or planning to become pregnant in the next year.
- I have a known allergy to metformin.
- I currently take metformin or topiramate.
- I have diabetes.
- I have kidney problems.
- I have had a previous ACL tear on the same knee.
- I have had an ACL tear on the other knee in the past year.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
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 t…
Trial Locations
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Eligibility Criteria
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 p…
Contacts