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

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: ACL Injury, Meniscus Tear, Post-traumatic Osteoarthritis

In brief

This is a multicenter randomized, placebo-controlled trial to assess whether a 6-month course of oral montelukast after ACL reconstruction reduces systemic markers of inflammation and biochemical and imaging biomarkers of cartilage degradation. This study will specifically target older ACL reconstruction patients with concomitant meniscal injuries as this group is at greatest risk of rapid PTOA progression. Patients will randomly be assigned to receive oral montelukast (10 mg) versus placebo daily for 6 months after surgery.

Key facts

Study ID

NCT04572256

Run by

Austin V Stone

People needed

30

Starts

2021-02-01

Expected to finish

2027-06-01

Last updated by the study team

2026-06-10

Who can join

Age: 25 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Undergoing primary ACL reconstruction
• Age between 25-50
• Concomitant meniscus injury

You may not qualify if…

• Undergoing revision procedures
• Multiple ligament injuries requiring multiple ligament reconstruction/repair
• Depressive symptoms and/or those who endorse suicidal ideation at the time of enrollment (PHQ-9 score >= 15)
• Found to not have a meniscus tear at the time of surgery

Where it is running

• UK Healthcare at Turfland — Lexington, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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