What this study is
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.
What's being tested
- Montelukast
Intervention · DRUG
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.
- Placebo
Intervention · DRUG
An oral placebo will be taken daily for 6 months post surgery.
Study details
- Sponsor
- Austin V Stone
- Conditions
- ACL Injury · Meniscus Tear · Post-traumatic Osteoarthritis
- Enrolling
- 30 people
- Starts
- 2021-02-01
- Est. completion
- 2027-06
- Design
- Quadruple-blind, randomized, parallel groups, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 25 Years – 50 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Undergoing primary ACL reconstruction
- Age between 25-50
- Concomitant meniscus injury
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUK Healthcare at Turfland
Lexington, Kentucky, United States
- Austin Stone, MD, PhD · Contact859-218-3065austin.stone@uky.edu
- Cale Jacobs, PhD · Sub-investigator
- Austin Stone, MD · Principal investigator
Recruiting
Study team
Sponsor
Austin V Stone
Study ID 60266
Principal investigator
Austin Stone, MD, PhD
University of Kentucky
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.