MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)
Austin V Stone
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.
Description
After anterior cruciate ligament (ACL) reconstruction, patient-reported outcomes are improved 10 years post-surgery. Cytokine concentrations, however, remain elevated years after surgery; over 80% of patients with combined ACL and meniscus injuries have post-traumatic osteoarthritis (PTOA) within 10-15 years after injury. Since pain nociceptors are not located in the articular cartilage, patient-reported outcomes improve despite progressive, irreversible cartilage loss, thus making PTOA a "silent killer." Because early cartilage loss progresses without pain and dysfunction, the prevalence of P…
Eligibility
- Age range
- 25–50 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugMontelukast
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.
- DrugPlacebo
An oral placebo will be taken daily for 6 months post surgery.
Location
- UK Healthcare at TurflandLexington, Kentucky