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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Austin V Stone
Study ID
NCT04572256
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • ACL Injury
  • Meniscus Tear
  • Post-traumatic Osteoarthritis

Eligibility Criteria

Sex
ALL
Age
25 Years - 50 Years
Healthy Volunteers
Not accepted

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.
  • Placebo — DRUG
    An oral placebo will be taken daily for 6 months post surgery.

Study Details

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.

Key Dates

Start date
Feb 1, 2021
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Serum prostaglandin E2 [ Time Frame: Change between Visit 3 (10 days post surgery) and Visit 6 (1 year post surgery) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UK Healthcare at TurflandLexingtonKentucky40504
Austin Stone, MD, PhD
[email protected]
859-218-3065
Cale Jacobs, PhD (SUB_INVESTIGATOR)
Austin Stone, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UK Healthcare at Turfland· Lexington, KY

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