MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)
Recruiting · NCT04572256 · Interventional (participants receive a specific treatment) · Lead sponsor: Austin V Stone
View the official record on ClinicalTrials.gov →Interventions studied
MontelukastPlacebo
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.
Who can take part
Age range
25 Years to 50 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Undergoing primary ACL reconstruction
- Age between 25-50
- Concomitant meniscus injury
Exclusion criteria
- 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
1 location listed across 1 US state.
- UK Healthcare at Turfland - Lexington, Kentucky, United States