NCT06096259 Preventing Injured Knees From osteoArthritis: Severity Outcomes
| NCT ID | NCT06096259 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 512 participants |
| Start Date | 2024-05-06 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 512 participants in total. It began in 2024-05-06 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
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 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
Contact & Investigator
Morgan H Jones, MD, MPH
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT06096259 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06096259 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06096259 currently recruiting?
Yes, NCT06096259 is actively recruiting participants. Contact the research team at fselzer@bwh.harvard.edu for enrollment information.
Where is the NCT06096259 trial being conducted?
This trial is being conducted at Atlanta, United States, Iowa City, United States, Lexington, United States, Boston, United States and 5 additional locations.
Who is sponsoring the NCT06096259 clinical trial?
NCT06096259 is sponsored by Brigham and Women's Hospital. The principal investigator is Morgan H Jones, MD, MPH at Brigham and Women's Hospital. The trial plans to enroll 512 participants.