Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
60266
Description
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.
Trial arms
Trial start
2021-02-01
Estimated PCD
2025-04-01
Trial end
2025-04-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Montelukast
Other names:
Singulair
Placebo
An oral placebo will be taken daily for 6 months post surgery.
Arms:
Placebo
Size
30
Primary endpoint
Serum prostaglandin E2
Change between Visit 3 (10 days post surgery) and Visit 6 (1 year post surgery)
T1rho relaxation time on MRI
Change between Visit 4 (4 weeks post surgery) and Visit 6 (1 year post surgery)
Shape of the medial femoral condyle on MRI
Change between Visit 4 (4 weeks post surgery) and Visit 6 (1 year post surgery)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Change between Visit 3 (10 days post surgery) and Visit 6 (1 year post surgery)
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-04-30

1 organization

1 product

1 drug

3 indications

Organization
Austin V Stone
Product
Montelukast
Indication
Anterior Cruciate Ligament (ACL) Injury
Indication
Meniscus Tear
Indication
Post-traumatic Osteoarthritis
Drug
Varlilumab