Phase 2Recruiting
Preventing Injured Knees From osteoArthritis: Severity Outcomes (PIKASO)
- Sponsor
- Brigham and Women's Hospital (Academic or other)
- Enrolment
- 512 planned
- Conditions
- Osteoarthritis, Knee; Post-traumatic Osteoarthritis; ACL Tear
- Interventions
- Metformin; Placebo
- Ages
- adults
- Registry
- NCT06096259
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- KOOS Pain Score
- Modified MOAKS Cartilage Score
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered