Status:
RECRUITING
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Arthritis Foundation
Conditions:
Osteoarthritis, Knee
Post-traumatic Osteoarthritis
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
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. Thi...
Detailed Description
Osteoarthritis (OA) is among the most prevalent chronic, disabling conditions, occurring in over 32 million persons in the US. Worldwide, an estimated 240 million persons have symptomatic, activity-li...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
512 Patients enrolled
Trial Details
Trial ID
NCT06096259
Start Date
May 6 2024
End Date
December 1 2029
Last Update
April 29 2025
Active Locations (9)
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1
Emory University
Atlanta, Georgia, United States, 30322
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
3
University of Kentucky
Lexington, Kentucky, United States, 40504
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115