Preventing Injured Knees From osteoArthritis: Severity Outcomes (PIKASO)

What this Trial Is About

This research aims to evaluate whether metformin can reduce pain by delaying the onset of post-traumatic osteoarthritis (PTOA) following anterior cruciate ligament (ACL) reconstruction. PTOA is a common condition that develops earlier in people who have had an ACL injury, impacting their quality of life and productivity. This multicenter, randomized, double-blind, placebo-controlled study focuses on younger adults who have undergone ACL reconstruction to assess the potential benefits of metformin, a drug with known anti-inflammatory effects. Participants will be randomly assigned to receive either metformin extended-release tablets or a matching placebo once daily for one year. The metformin dose starts at 500 mg once daily and may be increased every five days up to 1500 mg daily as tolerated. Both groups will follow standard postoperative physical therapy. The study will measure outcomes such as knee pain and cartilage condition using KOOS pain scores and modified MRI Osteoarthritis Knee Score (MOAKS) over 12 and 24 months. During the trial, participants will undergo regular assessments including questionnaires about pain, symptoms, daily activities, sports function, and quality of life at multiple time points up to 24 months. Additional evaluations include MRI scans, joint space measurements, knee range of motion, gait analysis, strength tests, and hop tests. Researchers will monitor participant safety and treatment adherence throughout the study, which is expected to last up to 24 months after surgery.

Preventing Injured Knees From osteoArthritis: Severity Outcomes