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RECRUITING
NCT06956339
NA

Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture

Sponsor: University of Melbourne

View on ClinicalTrials.gov

Summary

The aim of the EMBRACE clinical trial is to compare outcomes (knee pain, symptoms, function and quality of life) between people with anterior cruciate ligament (ACL) rupture who are managed with either a novel bracing protocol (Cross Bracing Protocol), or with ACL reconstruction surgery. The main question that the trial aims to answer is: In individuals with acute ACL rupture, is management with the Cross Bracing Protocol more clinically effective and cost effective compared to early ACL reconstruction surgery? 180 people across five Australian cities, with a recent ACL injury, will be randomly allocated to one of two treatments. 1. Cross Bracing Protocol People who are allocated to the bracing treatment will: * wear a knee brace for 12 weeks * see a sports doctor * have 23 visits to a physiotherapist who will supervise their knee rehab over 12 months. * have two knee scans; 3 and 18 months after they enrol 2. Anterior Cruciate Ligament Reconstruction Surgery People who are allocated to the surgery group will: * have surgery within 8 weeks of enrolling in the study * have 15 visits to a physiotherapist for their knee rehab over 12 months after surgery. * have one knee scan 18 months after they enrol. All participants will: * complete surveys at the beginning and 3, 6, 12 and 18 months later so the main trial outcomes can be collected, as well as additional information about their knee. * have knee imaging (Magnetic Resonance Imaging or MRI scan) so the overall condition of their knee can be assessed, as well as whether their ACL has healed.

Official title: Evaluating Non-surgical Management of Acute Anterior Cruciate Ligament Rupture With a Novel BRACE Protocol Versus Early Surgical Reconstruction - a Comparative Effectiveness Randomised Controlled Trial

Key Details

Gender

All

Age Range

16 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-08

Completion Date

2029-03

Last Updated

2025-07-25

Healthy Volunteers

No

Interventions

PROCEDURE

Early anterior cruciate ligament surgery

Participants randomised to early anterior cruciate ligament reconstruction surgery (ACLR) will be referred to a study orthopaedic surgeon. Participants will have surgery within 8 weeks of randomisation. The ACLR will reflect usual care for each surgeon. Participants will undergo routine preoperative care, including an anaesthetic consultation to assess fitness for surgery and general anaesthesia. Surgeons will choose their preferred surgical technique and graft, and treat concomitant injuries surgically if indicated and aligned with their usual practice. Participants will follow the surgeon's standard recommendations regarding post-operative care and appointments. Participants will be provided with 15 funded physiotherapy consultations within 12 months of surgery and undertake a physiotherapist-supervised goal-oriented exercise-based rehabilitation program.

OTHER

Novel bracing protocol

Participants will undertake the Cross Bracing Protocol under the supervision of a study physiotherapist (23 funded physiotherapy sessions within 12 months). Medical oversight and venous thromboembolism prophylaxis will be provided by the study sports and exercise medicine physician. A specialised knee brace will be fitted within 21 days of ACL injury. The knee is kept at 90° flexion in the brace at all times for the first four weeks. The brace is then adjusted weekly by the physiotherapist to allow progressive increases in knee range (60-90° flexion at 5 weeks, 45-90° flexion at 6 weeks, 30° to full flexion at 7 weeks, 20° to full flexion at 8 weeks, 10° to full flexion at 9 weeks, unrestricted range at 10 weeks, brace off at 12 weeks). Whilst braced and after brace removal, the participant will undertake physiotherapist-supervised goal-oriented exercise-based rehabilitation within the available knee range.

Locations (1)

The University of Melbourne

Melbourne, Victoria, Australia