Recruiting
Early Phase 1

Montelukast

Sponsor:

Austin V Stone

Code:

NCT04572256

Conditions

ACL Injury

Meniscus Tear

Post-traumatic Osteoarthritis

Eligibility Criteria

Sex: All

Age: 25 - 50

Healthy Volunteers: Not accepted

Interventions

Montelukast

Placebo

Study Details

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

Study ID

NCT04572256

Start date

Feb 1, 2021

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Montelukast

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

placebo comparator: Placebo

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

Interventions

Montelukast

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.

Placebo

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

Primary outcome measure

  • Serum prostaglandin E2 [ Time Frame: Change between Visit 3 (10 days post surgery) and Visit 6 (1 year post surgery) ]
  • T1rho relaxation time on MRI [ Time Frame: Change between Visit 4 (4 weeks post surgery) and Visit 6 (1 year post surgery) ]
  • Shape of the medial femoral condyle on MRI [ Time Frame: Change between Visit 4 (4 weeks post surgery) and Visit 6 (1 year post surgery) ]
  • Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Change between Visit 3 (10 days post surgery) and Visit 6 (1 year post surgery) ]

Central Contacts and Locations

Central contacts

Austin Stone, MD, PhD

859.218.3065austin.stone@uky.edu

Locations

UK Healthcare at Turfland

Recruiting

Lexington, Kentucky, United States, 40504

Contacts

Austin Stone, MD, PhD

859-218-3065austin.stone@uky.edu

Principal Investigator:

Austin Stone, MD

More Information

Sponsor

Austin V Stone

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • knee ligament
  • osteoarthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Austin V Stone on 2026-06-10.