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MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)

RECRUITINGEarly 1Sponsored by Austin V Stone
Actively Recruiting
PhaseEarly 1
SponsorAustin V Stone
Started2021-02-01
Est. completion2027-06
Eligibility
Age25 Years – 50 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT04572256

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

Age: 25 Years – 50 YearsHealthy volunteers accepted
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

Conditions4

ACL InjuryArthritisMeniscus TearPost-traumatic Osteoarthritis

Locations1 site

UK Healthcare at Turfland
Lexington, Kentucky, 40504
Austin Stone, MD, PhD859-218-3065austin.stone@uky.edu

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