Overview

Preventing Injured Knees From osteoArthritis: Severity Outcomes

Status:
Recruiting

Trial end date:
2029-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Brigham and Women's Hospital

Collaborator:

Arthritis Foundation

Treatments:

Metformin

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. ACL tear documented on MRI within 6 months prior to screening

3. Plan to undergo ACL reconstruction

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. Type I diabetes mellitus or diabetic ketoacidosis

6. Heavy alcohol consumption and/or known hepatic disease

7. Acute or chronic renal insufficiency

8. History of ACLR on either knee

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. 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

19. Plan for allograft at time of consent