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

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cale Jacobs, PhD; University of Kentucky
• Collaborators: Duke University; The Cleveland Clinic; University of California, San Francisco
• Treatments: Montelukast

Criteria

Inclusion Criteria:

1. Undergoing primary ACL reconstruction

2. Age between 25-50

3. Concomitant meniscus injury

Exclusion Criteria:

1. Undergoing revision procedures

2. Multiple ligament injuries requiring multiple ligament reconstruction/repair

3. Depressive symptoms and/or those who endorse suicidal ideation at the time of enrollment (PHQ-9 score >= 15)

4. Found to not have a meniscus tear at the time of surgery