Montelukast for protecting cartilage after ACL surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized, placebo-controlled trial investigates the effects of a 6-month course of oral montelukast on reducing inflammation and cartilage degradation following anterior cruciate ligament (ACL) reconstruction. Targeting older patients with ACL and meniscus injuries, the study aims to determine if montelukast can mitigate the risk of post-traumatic osteoarthritis (PTOA) progression. Participants will be randomly assigned to receive either montelukast or a placebo daily for six months after their surgery, with assessments of systemic inflammation and cartilage biomarkers conducted throughout the study.

Why it matters

Who can join: the full rules

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

Where it's running

• UK Healthcare at Turfland
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Austin Stone, MD, PhD — University of Kentucky
• Study coordinator: Austin Stone, MD, PhD
• Email: austin.stone@uky.edu
• Phone: 859.218.3065

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Motor imagery–enhanced rehab after ACL reconstruction

  This study tests whether mentally practicing movement can improve knee function and brain activity after ACL reconstruction, in comparison with standard rehab.

  Recruiting Peking University Third Hospital · Beijing, Beijing Municipality · NCT07833189

• Functional Movement Training vs Functional Stability Training after ACL Surgery

  This randomized trial tests whether a functional movement program or a stability-focused program helps 18-35 year old athletes recover after ACL surgery.

  Recruiting Riphah International University · Lahore, Punjab Province · NCT07725016

• Intraoperative Energy Use During ACL Surgery

  This study tests how much workload a surgeon experiences during ACL reconstruction procedures while wearing a Hexoskin shirt.

  Recruiting ASL Lecce · Lecce · NCT07683247

• Differences in Outcomes After Allograft vs Autograft in Revision ACL Repair

  This study looks at whether using donor tissue (allograft) versus the patient’s own tissue (autograft) in revision ACL surgery leads to different results.

  Recruiting Istituto Ortopedico Rizzoli · Bologna, Bologna · NCT07671235

• Magic Angle Direction Imaging for ACL tears and meniscus injuries

  This study tries a new low-field MRI technique called Magic Angle Direction Imaging to see if it shows ACL tears and meniscus injuries more clearly in adults scheduled for ligament repair.

  Recruiting at 2 sites Imperial College London · London and 1 other locations · NCT07366619

• Functional brain signal changes after ACL reconstruction with targeted neuromotor training

  This project will test whether targeted neuromotor training after ACL reconstruction changes brain activity patterns in active adults aged 18–30.

  Recruiting Istituto Ortopedico Rizzoli · Bologna, Bologna · NCT07097077

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.