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Early Phase 1
Age: 25Years - 50Years
All Genders
ID04572256

Evaluating Oral Montelukast for Protecting Knee Cartilage After Anterior Cruciate Ligament Reconstruction in Adults Aged 25 to 50 with Meniscus Injury

Led by Austin V Stone · Updated on 2026-06-10

30

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether a six-month course of oral montelukast can reduce inflammation and cartilage breakdown after anterior cruciate ligament ACL reconstruction in patients aged 25 to 50 who also have meniscus injuries. This randomized, placebo-controlled trial focuses on older patients at high risk for rapid post-traumatic osteoarthritis PTOA, a condition that often progresses silently despite improvements in pain and function. The study aims to explore montelukasts potential as a disease-modifying treatment by targeting inflammatory pathways involved in cartilage degradation and joint damage. Participants will be randomly assigned to receive either 10 mg of oral montelukast or a matching placebo daily for six months following their ACL reconstruction surgery. Montelukast works by blocking pro-inflammatory signals that contribute to tissue damage in the knee joint. The trial monitors the effects of this treatment on biochemical markers, MRI measures of cartilage and bone changes, and patient-reported outcomes over the course of one year. During the study, participants will undergo assessments including blood tests to measure inflammation, MRI scans to evaluate cartilage and bone structure, and questionnaires to report knee symptoms and function. Key outcomes include changes in serum prostaglandin E2 levels, MRI relaxation times, shape of the medial femoral condyle, and Knee injury and Osteoarthritis Outcome Scores KOOS from shortly after surgery to one year later. The study will also monitor safety and treatment adherence throughout the trial period.

CONDITIONS

Brief Title

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

Research Team

A

Austin Stone, MD, PhD

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