Study of Oral Alendronate Treatment to Improve Knee Function After ACL Reconstruction Surgery A Multi-Center, Double-Blind, Placebo-Controlled Phase 4 Trial

What this Trial Is About

Anterior cruciate ligament ACL tears are common injuries that affect the knees stability and can lead to post-traumatic osteoarthritis. This trial evaluates the effects of oral alendronate ALN, a medication known for its bone-protecting properties, on knee function and healing after ACL reconstruction surgery. The study is a phase 4, multi-center, double-blind, randomized controlled trial comparing ALN to placebo in patients undergoing ACL reconstruction. Participants will receive a weekly oral dose of 70 mg of ALN or a placebo for 8 weeks, alongside a standard rehabilitation program. ALN has been chosen due to its high bone-binding ability and longer action duration, with previous animal studies supporting its potential benefits. The placebo used is manufactured under strict quality standards. Both groups will undergo the same rehabilitation protocol to ensure consistency. During the 12-month study, participants will be assessed on knee stability, bone changes around the surgical tunnels, knee laxity, muscle strength, and self-reported knee symptoms and function. The primary outcome is measured by changes in the Single-leg Hop Test at 4.5, 6, and 12 months. Safety and tolerability of ALN are monitored, with known side effects including mild gastrointestinal symptoms. The trial aims to improve recovery outcomes following ACL reconstruction.

A Multi-centre, Double-blind RCT to Investigate the Effect of Alendronate on Knee Function Following ACLR