Comparing a New Knee Bracing Method with Early Surgery for Acute Anterior Cruciate Ligament Rupture in Young Adults

What this Trial Is About

This research aims to compare outcomes such as knee pain, symptoms, function, and quality of life in people with an acute anterior cruciate ligament ACL rupture. It evaluates whether a novel Cross Bracing Protocol is more clinically and cost effective compared to early ACL reconstruction surgery. The trial includes 180 participants across five Australian cities who have recently experienced an ACL injury. Participants will be randomly assigned to one of two treatments. The Cross Bracing Protocol group will wear a specialized knee brace for 12 weeks, starting with the knee bent at 90 degrees, followed by progressive increases in knee movement guided by a physiotherapist over 12 months, including 23 supervised rehab visits and medical oversight. The surgery group will have ACL reconstruction within 8 weeks, followed by 15 physiotherapy sessions over 12 months. Both groups will undergo knee scans to monitor healing the bracing group has scans at 3 and 18 months, while the surgery group has one at 18 months. Throughout the 18-month trial, participants will complete surveys at multiple time points to report knee pain, symptoms, function, and quality of life using standardized questionnaires. Knee imaging MRI will assess the overall condition and healing of the ACL. Researchers will also track safety events, re-injury rates, knee stability, fear of re-injury, and satisfaction with knee function. The study is carefully monitored to understand the effectiveness and impact of both treatment approaches.

Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture