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Preventing Injured Knees From osteoArthritis: Severity Outcomes

NCT ID: NCT06096259
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: Brigham and Women's Hospital
Conditions: ACL Tear, Osteoarthritis, Knee, Post-traumatic Osteoarthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Preventing Injured Knees From osteoArthritis: Severity Outcomes (PIKASO)

Enrollment: 512 participants (Estimated).

What is being studied

Intervention: Amidines
Intervention: Biguanides
Intervention: Guanidines
Drug: Metformin
Intervention: Metformin
Intervention: Organic Chemicals
Drug: Placebo

Who may be eligible

Ages: 18 Years to 45 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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

Study locations

9 study locations are listed.

Recruiting site status is explicitly provided for 9 locations; 9 are listed as Recruiting.

Countries: United States

Georgia, United States: 1
Iowa, United States: 1
Kentucky, United States: 1
Massachusetts, United States: 1
Nebraska, United States: 1
New York, United States: 1
North Carolina, United States: 1
Ohio, United States: 2

Sample of listed locations

Emory University — Atlanta, Georgia, 30322, United States — Recruiting
University of Iowa Hospitals and Clinics — Iowa City, Iowa, 52242, United States — Recruiting
University of Kentucky — Lexington, Kentucky, 40504, United States — Recruiting
Brigham and Women's Hospital — Boston, Massachusetts, 02115, United States — Recruiting
University of Nebraska Medical Center — Omaha, Nebraska, 68198, United States — Recruiting
Hospital for Special Surgery — New York, New York, 10021, United States — Recruiting
The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, 25599, United States — Recruiting
Cleveland Clinic — Cleveland, Ohio, 44195, United States — Recruiting
The Ohio State University — Columbus, Ohio, 43210, United States — Recruiting

Study details

Start date: May 6, 2024
Primary completion date: December 1, 2029
Completion date: December 1, 2030
First posted: October 23, 2023
Collaborators: Arthritis Foundation

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06096259
Registry last updated: October 15, 2026
QualifiedStudies registry data refreshed: October 19, 2026
QualifiedStudies record fetched: October 19, 2026

View NCT06096259 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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