RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-02-01
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04572256

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Undergoing primary ACL reconstruction
  2. 2. Age between 25-50
  3. 3. Concomitant meniscus injury
  1. 1. Undergoing revision procedures
  2. 2. Multiple ligament injuries requiring multiple ligament reconstruction/repair
  3. 3. Depressive symptoms and/or those who endorse suicidal ideation at the time of enrollment (PHQ-9 score \>= 15)
  4. 4. Found to not have a meniscus tear at the time of surgery

Contacts and Locations

Study Contact

Austin Stone, MD, PhD
CONTACT
859.218.3065
austin.stone@uky.edu

Principal Investigator

Austin Stone, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

UK Healthcare at Turfland
Lexington, Kentucky, 40504
United States

Collaborators and Investigators

Sponsor: Austin V Stone

  • Austin Stone, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-01
Study Completion Date2025-04

Study Record Updates

Study Start Date2021-02-01
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • knee ligament
  • osteoarthritis

Additional Relevant MeSH Terms

  • ACL Injury
  • Meniscus Tear
  • Post-traumatic Osteoarthritis