Using metformin to reduce knee pain after ACL surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of metformin in reducing pain and delaying the onset of post-traumatic osteoarthritis (PTOA) following anterior cruciate ligament (ACL) reconstruction. Participants will be randomly assigned to receive either metformin or a placebo, which looks identical but contains no active medication. The study aims to determine if metformin's known anti-inflammatory properties can benefit individuals recovering from ACL injuries. By focusing on a specific age group and preoperative pain levels, the study seeks to identify those most likely to benefit from this intervention.

Why it matters

Who can join: the full rules

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

Where it's running

• Emory University
  Atlanta, Georgia, United States Recruiting
• University of Iowa Hospitals and Clinics
  Iowa City, Iowa, United States Recruiting
• University of Kentucky
  Lexington, Kentucky, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting
• Hospital for Special Surgery
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Morgan H Jones, MD, MPH — Brigham and Women's Hospital
• Study coordinator: Faith Selzer, PhD
• Email: fselzer@bwh.harvard.edu
• Phone: 617-525-8617

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.