MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age25-50
SponsorAustin V Stone
About this trial
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.
Eligibility criteria
Qualifiers
Undergoing primary ACL reconstruction
Age between 25-50
Concomitant meniscus injury
Disqualifiers
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
Trial design
Treatments tested in this trial
- Montelukast
- Placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
1UK Healthcare at Turfland40504, LexingtonKentucky, United States
Sponsors and collaborators
Austin V Stone
Lead sponsor
University of Kentucky
Sponsor institution
Duke University
Collaborator
The Cleveland Clinic
Collaborator
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov