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

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.

Conditions

ACL Injury, Meniscus Tear, Post-traumatic Osteoarthritis

Study Overview

Study Details

Study overview

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.

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

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

Condition
ACL Injury
Intervention / Treatment

-

Contacts and Locations

Lexington

UK Healthcare at Turfland, Lexington, Kentucky, United States, 40504

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Undergoing primary ACL reconstruction
  • 2. Age between 25-50
  • 3. Concomitant meniscus injury
  • 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

Ages Eligible for Study

25 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Austin V Stone,

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

Study Record Dates

2025-04