The PIKASO trial, a significant step forward in the fight against post-traumatic osteoarthritis (PTOA), focuses on individuals aged 18–45 years who are undergoing anterior cruciate ligament reconstruction (ACLR). This condition, known for its high burden and increasing prevalence, poses a significant risk to the quality of life of affected individuals. The trial is designed as a multicenter, blinded, parallel, two-arm randomized controlled study involving 512 participants. Its primary objective is to evaluate the effectiveness of a 12-month intervention using oral metformin versus a placebo in reducing the rate of structural knee changes and alleviating pain.
Participants in the trial will be administered up to 1500 mg/day of either metformin or placebo, as tolerated. The study's primary outcomes include the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subscale scores, averaged between 12 and 24 months post-randomization, and MRI-derived cartilage structural changes at the 24-month mark. The trial's success hinges on at least one of these primary outcomes achieving the preplanned effect size with sufficient statistical certainty.
This innovative approach, developed by a multidisciplinary team, aims to determine whether metformin can alter pain and early osteoarthritic changes following ACLR. By outlining the rationale, study design, and implementation of the PIKASO trial, this research offers a promising avenue for preventing the onset of PTOA after ACLR, potentially improving the quality of life for those at high risk of developing the disease.
