Actively Recruiting
MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)
Led by Austin V Stone · Updated on 2025-05-08
30
Participants Needed
1
Research Sites
330 weeks
Total Duration
On this page
Sponsors
A
Austin V Stone
Lead Sponsor
D
Duke University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing primary ACL reconstruction
- Age between 25 and 50 years
- Having a meniscus injury at the time of surgery
You will not qualify if you...
- Undergoing revision ACL procedures
- Having multiple ligament injuries that require complex reconstruction or repair
- Experiencing depressive symptoms or suicidal thoughts at enrollment (PHQ-9 score \u2265 15)
- Not having a meniscus tear found during surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UK Healthcare at Turfland
Lexington, Kentucky, United States, 40504
Actively Recruiting
Research Team
A
Austin Stone, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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