MOCHA Trial: Montelukast for ACL Reconstruction Recovery
This study, called the MOCHA Trial, is testing if a medication called montelukast can help prevent cartilage damage after surgery for an ACL (anterior cruciate ligament) injury. After ACL surgery, many people develop post-traumatic osteoarthritis (PTOA), which is a type of arthritis that causes cartilage to wear away. Researchers believe montelukast might reduce inflammation and slow down this cartilage damage. You might be able to join if you are between 25 and 50 years old, are having your first ACL reconstruction, and also have a meniscus tear. The study will look at changes in your blood and on MRI scans to see if montelukast is effective. The current recruitment status is unclear.
- Study design
- This is a randomized, placebo-controlled study involving 30 participants. Participants will be randomly assigned to receive either montelukast or a placebo.
- What's involved
- You would take either montelukast or a placebo daily for 6 months after your surgery. You would have blood tests at 10 days and 1 year post-surgery, and MRI scans at 4 weeks and 1 year post-surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for 1 year after your surgery to measure changes in blood markers and MRI scans.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Austin Stone, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky
Who to contact
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What this trial measures
- Serum prostaglandin E2Change between Visit 3 (10 days post surgery) and Visit 6 (1 year post surgery)
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.
- T1rho relaxation time on MRIChange between Visit 4 (4 weeks post surgery) and Visit 6 (1 year post surgery)
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.
- Shape of the medial femoral condyle on MRIChange between Visit 4 (4 weeks post surgery) and Visit 6 (1 year post surgery)
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.
- Knee injury and Osteoarthritis Outcome Score (KOOS)Change between Visit 3 (10 days post surgery) and Visit 6 (1 year post surgery)
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.