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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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Montelukast
Placebo
Usual Standard of Care
What it is
Daily oral montelukast for six months following ACL reconstruction in individuals with a meniscus injury
Daily oral placebo for six months after surgery
Standard rehabilitation and post‑ACLR care without disease‑modifying medications
Role in trial
Investigational treatment being evaluated for chondroprotective effect
Randomized control comparator arm
Usual care reference without investigational drug
Primary use
Tested as a disease‑modifying therapy to protect cartilage after ACL reconstruction
Control comparator without active drug
Standard postoperative rehabilitation without investigational medication
How it is given or performed
Oral tablet taken daily for six months post surgery
Oral placebo tablet taken daily for six months post surgery
Physical therapy and rehabilitation protocols without an added drug
Evidence status
Evidence not yet established for chondroprotective effect in humans
Control arm, no active efficacy expected
Rehabilitation is recommended to reduce long‑term risk of osteoarthritis
Important risks
Safety in this post‑ACL reconstruction context not yet determined
No active pharmacologic risk expected
No added drug‑related risks; physical therapy safety depends on standard precautions
Important limitations
Unproven in this indication; outcomes not yet available; limited to ages 25‑50 with meniscus injury
Only serves as control; does not reflect active therapy
Does not include potential pharmacologic chondroprotection; outcomes may vary
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 25Years - 50Years
All Genders
Eligibility Criteria
You may qualify if you...
Undergoing primary ACL reconstruction
Age between 25-50 years
Concomitant meniscus injury
You will not qualify if you...
Undergoing revision ACL procedures
Multiple ligament injuries requiring reconstruction or repair
Depressive symptoms or suicidal thoughts at enrollment (PHQ-9 score ≥ 15)
No meniscus tear found at time of surgery
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 6 months
Participants take oral montelukast or placebo daily for six months following ACL reconstruction surgery.
Daily medication intake
Follow-up
Duration - Up to 1 year
Participants undergo blood tests, MRI scans, and complete questionnaires to monitor inflammation, cartilage condition, and knee function up to one year after surgery.
Multiple visits including assessments at 10 days, 4 weeks, and 1 year post surgery
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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Published Research Related To This Trial
MOntelukast as a potential CHondroprotective treatment following Anterior cruciate ligament reconstruction (MOCHA Trial): study protocol for a double-blind, randomized, placebo-controlled clinical trial.
Cale A Jacobs, Caitlin E W Conley, Virginia Byers Kraus...