MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)

What this Trial Is About

Researchers are studying whether a 6-month course of oral montelukast after anterior cruciate ligament (ACL) reconstruction can reduce inflammation and cartilage damage in patients who have both ACL and meniscus injuries. This trial focuses on older patients aged 25 to 50 who are at high risk of developing post-traumatic osteoarthritis (PTOA), a condition that leads to cartilage loss and joint problems over time despite improved patient-reported outcomes after surgery. The study aims to explore montelukast's potential as a disease-modifying treatment to slow or prevent cartilage degradation following surgery. Participants will be randomly assigned to receive either 10 mg of oral montelukast or a placebo daily for six months after their ACL reconstruction surgery. Montelukast is known to block certain pro-inflammatory pathways involved in cartilage breakdown and bone remodeling. The study is conducted as a multicenter, randomized, placebo-controlled trial with quadruple masking to compare the effects of montelukast versus placebo. Throughout the study, patients will be monitored with blood tests measuring prostaglandin E2, MRI scans assessing cartilage and bone changes, and patient-reported knee function scores over one year following surgery. These assessments occur at specific time points, including 10 days, 4 weeks, and 1 year after surgery. The research team will evaluate changes in inflammation markers, cartilage condition, and knee health to determine montelukast's impact on post-surgical recovery and PTOA progression.

MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)