Montelukast for protecting cartilage after ACL surgery
MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)
This study is testing if taking montelukast for six months after ACL surgery can help older patients reduce inflammation and protect their cartilage from damage.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 25 Years to 50 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT04572256 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized, placebo-controlled trial investigates the effects of a 6-month course of oral montelukast on reducing inflammation and cartilage degradation following anterior cruciate ligament (ACL) reconstruction. Targeting older patients with ACL and meniscus injuries, the study aims to determine if montelukast can mitigate the risk of post-traumatic osteoarthritis (PTOA) progression. Participants will be randomly assigned to receive either montelukast or a placebo daily for six months after their surgery, with assessments of systemic inflammation and cartilage biomarkers conducted throughout the study.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 25-50 who are undergoing primary ACL reconstruction with a concomitant meniscus injury.
Not a fit: Patients undergoing revision procedures or those without a meniscus tear at the time of surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of developing post-traumatic osteoarthritis in patients undergoing ACL reconstruction.
How similar studies have performed: While the approach of using montelukast for cartilage protection is novel, previous studies have shown promise in using anti-inflammatory treatments to reduce cartilage degradation post-injury.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lexington, Kentucky
- UK Healthcare at Turfland — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Austin Stone, MD, PhD — University of Kentucky
- Study coordinator: Austin Stone, MD, PhD
- Email: austin.stone@uky.edu
- Phone: 859.218.3065
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.