Actively Recruiting

Early Phase 1
Age: 25Years - 50Years
All Genders
NCT04572256

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

Led by Austin V Stone · Updated on 2025-05-08

30

Participants Needed

1

Research Sites

330 weeks

Total Duration

On this page

Sponsors

A

Austin V Stone

Lead Sponsor

D

Duke University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 25Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing primary ACL reconstruction
  • Age between 25 and 50 years
  • Having a meniscus injury at the time of surgery
Not Eligible

You will not qualify if you...

  • Undergoing revision ACL procedures
  • Having multiple ligament injuries that require complex reconstruction or repair
  • Experiencing depressive symptoms or suicidal thoughts at enrollment (PHQ-9 score \u2265 15)
  • Not having a meniscus tear found during surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UK Healthcare at Turfland

Lexington, Kentucky, United States, 40504

Actively Recruiting

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Research Team

A

Austin Stone, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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