The PIKASO trial (Preventing Injured Knees from Osteoarthritis: Severity Outcomes): Rationale and design features for...

Area of Science:

• Orthopedics
• Pharmacology
• Clinical Trials

Background:

• Post-traumatic osteoarthritis (PTOA) presents a significant health burden with increasing prevalence.
• Early intervention strategies are crucial for individuals at high risk of developing PTOA after knee injury.

Purpose of the Study:

• To evaluate the efficacy of oral metformin in preventing or delaying the onset of PTOA following anterior cruciate ligament reconstruction (ACLR).
• To assess metformin's impact on structural knee changes and pain levels in patients undergoing ACLR.

Main Methods:

• A multicenter, blinded, randomized controlled trial (PIKASO) involving 512 participants aged 18-45 years undergoing ACLR.
• Participants received either 1500 mg/day of oral metformin or a placebo for 12 months.
• Primary outcomes include Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subscale scores (12-24 months) and MRI-derived cartilage structural changes (24 months).

Main Results:

• The study is designed to determine if metformin alters pain and early osteoarthritic changes after ACLR.
• Statistical analysis will assess the effect size for primary outcomes to determine trial success.

Conclusions:

• This trial aims to provide evidence for a novel therapeutic approach to mitigate PTOA development after ACLR.
• Findings could lead to improved quality of life for individuals susceptible to PTOA.