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

NCT04572256 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 60266
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

knee ligament; osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Serum prostaglandin E2

  Prostaglandin E2 is a potential inflammatory mediator, and it is being measured to directly assess whether treatment reduces this systemic inflammatory marker. Greater serum prostaglandin is associated with greater inflammation.

  Change between Visit 3 (10 days post surgery) and Visit 6 (1 year post surgery)

• T1rho relaxation time on MRI

  T1rho relaxation time is a validated measure of proteoglycan content within the cartilage, and can be assessed on MRI. Increased T1rho relaxation time is associated with increased cartilage degeneration.

  Change between Visit 4 (4 weeks post surgery) and Visit 6 (1 year post surgery)

• Shape of the medial femoral condyle on MRI

  The shape of the medial femoral condyle has been previously demonstrated to change after ACL reconstruction and is predictive of later cartilage changes. Flattening and widening of the medial femoral condyle are considered to be indicative of later cartilage changes.

  Change between Visit 4 (4 weeks post surgery) and Visit 6 (1 year post surgery)

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  The KOOS is a patient-reported outcome instrument that is comprised of 5 subscales (Pain, Symptoms, Activities of Daily Living, Sports and Recreation, and Quality of Life) with each scale being scored from 0 to 100 with higher scores being indicative of a superior outcome.

  Change between Visit 3 (10 days post surgery) and Visit 6 (1 year post surgery)

Study Arms (2)

Montelukast

EXPERIMENTAL

Patients will receive oral montelukast (10 mg) daily for 6 months after surgery.

Drug: Montelukast

Placebo

PLACEBO COMPARATOR

Patients will receive an oral placebo daily for 6 months after surgery.

Drug: Placebo

Interventions

Montelukast 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.

Also known as: Singulair

Montelukast

Placebo DRUG

An oral placebo will be taken daily for 6 months post surgery.

Placebo

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Undergoing primary ACL reconstruction
• Age between 25-50
• Concomitant meniscus injury

You may not qualify 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

Sponsors & Collaborators

• Austin V Stone: lead
• Duke University: collaborator
• The Cleveland Clinic: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

UK Healthcare at Turfland

Lexington, Kentucky, 40504, United States

RECRUITING

Related Publications (1)

• Jacobs CA, Conley CEW, Kraus VB, Lansdown DA, Lau BC, Li X, Majumdar S, Spindler KP, Lemaster NG, Stone AV. MOntelukast as a potential CHondroprotective treatment following Anterior cruciate ligament reconstruction (MOCHA Trial): study protocol for a double-blind, randomized, placebo-controlled clinical trial. Trials. 2022 Jan 31;23(1):98. doi: 10.1186/s13063-021-05982-3.

  PMID: 35101085 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Osteoarthritis

Interventions

montelukast

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Austin Stone, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Austin Stone, MD, PhD

CONTACT

859.218.3065; austin.stone@uky.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research Orthopedic Surgery

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 1, 2020
• Study Start: February 1, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)