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Search / Trial NCT04572256

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

Launched by AUSTIN V STONE · Sep 25, 2020

Trial Information

Current as of May 25, 2025

Recruiting

Keywords

Knee Ligament Osteoarthritis

ClinConnect Summary

The MOCHA Trial is a research study looking at whether a medication called montelukast can help protect the cartilage in the knee after surgery to fix a torn anterior cruciate ligament (ACL). This trial focuses on patients aged 25 to 50 who are having their first ACL surgery and also have a meniscus injury, as they are at higher risk for developing arthritis in the knee later on. Participants in the study will be randomly assigned to take either montelukast or a placebo (a pill that looks the same but has no active ingredients) for six months after their surgery.

If you're considering this trial, you would need to be between 25 and 50 years old, undergoing your first ACL surgery, and have a meniscus tear. Unfortunately, if you've had previous knee surgeries or have other serious injuries in your knee, you may not be eligible. Throughout the study, the researchers will monitor your health to see if taking montelukast can lower inflammation and help protect your knee joint. This trial is currently recruiting participants, and it could be a valuable opportunity to contribute to important research while receiving care for your injury.

Gender

ALL

Eligibility criteria

  • 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

About Austin V Stone

Austin V. Stone is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on enhancing patient outcomes, the organization specializes in the design, management, and execution of clinical trials across various therapeutic areas. Leveraging a team of experienced professionals and a robust network of clinical sites, Austin V. Stone emphasizes rigorous scientific methodologies and ethical standards to ensure the integrity and reliability of trial results. The sponsor is dedicated to fostering collaboration with researchers, healthcare providers, and regulatory bodies to bring groundbreaking treatments to market efficiently and safely.

Locations

Lexington, Kentucky, United States

Patients applied

0 patients applied

Trial Officials

Austin Stone, MD, PhD

Principal Investigator

University of Kentucky

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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