MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)
Austin V Stone
30 participants
Feb 1, 2021
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- Undergoing primary ACL reconstruction
- Age between 25-50
- Concomitant meniscus injury
Exclusion Criteria4
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The novel use of oral montelukast offers the potential of a disease modifying treatment to prevent irreversible cartilage loss after ACL injury. 10mg of oral Montelukast will be taken daily for 6 months post surgery.
An oral placebo will be taken daily for 6 months post surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04572256