MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial): Study Protocol for a Double-Blind, Randomized, Placebo-Controlled Clinical Trial

As part of this pilot randomized, placebo-controlled trial, we 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. Patients will be assessed at baseline and 6 and 12 months. In addition, we will perform secondary analyses of previously collected MRI scans to vet bone shape change after ACL reconstruction as a viable biomarker and determine if these changes are altered by preoperative corticosteroid injection. II. SPECIFIC AIMS AIM #1: Determine if a 6-month course of daily oral montelukast alters the biochemical mechanisms of PTOA when compared to placebo. AIM #2: Assess the effect of oral montelukast on cartilage degradation and bone remodeling after ACL reconstruction. AIM #3: Assess factors that influence bone shape changes on MRI following ACL reconstruction, and determine if preoperative corticosteroid injection alters postoperative bone shape changes.