Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture

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.

Conditions

• Anterior Cruciate Ligament Rupture

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.

Sponsors & Collaborators

• University of Melbourne

  lead OTHER

Principal Investigators

• Stephanie Filbay · University of Melbourne

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-07

Primary Completion

2029-11-30

Completion

2030-03-31

Countries

• Australia

Study Locations