Montelukast for ACL Injury (MOCHA Trial)

Phase < 1

Recruiting

Led By Austin Stone, MD, PhD

Research Sponsored by Austin V Stone

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 25-50

Concomitant meniscus injury

Must not have

Found to not have a meniscus tear at the time of surgery

Undergoing revision procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between visit 4 (4 weeks post surgery) and visit 6 (1 year post surgery)

Summary

This trial will test whether montelukast can reduce markers of inflammation and cartilage degradation in people who have undergone ACL reconstruction, specifically targeting those with additional meniscal injuries who are at greater risk of rapid cartilage degradation.

Who is the study for?

The MOCHA trial is for people aged 25-50 who are having their first ACL reconstruction and also have a meniscus injury. It's not for those without a meniscus tear, with multiple ligament injuries needing more complex surgery, or showing signs of depression or suicidal thoughts at enrollment.

What is being tested?

This study tests if taking montelukast (10 mg) daily for 6 months after ACL surgery can lower inflammation and slow down cartilage damage compared to a placebo. Participants will be randomly chosen to get either the drug or placebo.

What are the potential side effects?

Montelukast may cause side effects like respiratory issues, fever, headache, sore throat, cough, abdominal pain, diarrhea, influenza-like symptoms but specific side effects in this trial context aren't detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 25 and 50 years old.

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I have a concurrent meniscus injury.

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I am scheduled for my first ACL surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My surgery revealed I do not have a meniscus tear.

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I am scheduled for a corrective surgery.

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I need surgery to fix several torn ligaments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between visit 4 (4 weeks post surgery) and visit 6 (1 year post surgery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between visit 4 (4 weeks post surgery) and visit 6 (1 year post surgery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between visit 4 (4 weeks post surgery) and visit 6 (1 year post surgery) for reporting.