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

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 40
Healthy Volunteers: f
View:

• Aged 16 to 40 years;

• Have a primary and acute ACL rupture (complete tear) confirmed by MRI scan;

• At least moderately active before the ACL injury (a score of 5 to 10 on the Tegner Activity Scale before the injury);

• Willing and able to give informed consent and participate fully in the interventions and assessment procedures;

• Willing and able to cover the out-of-pocket costs associated with ACLR surgery.

Locations
Other Locations
Australia
The University of Melbourne
RECRUITING
Melbourne
Contact Information
Primary
EMBRACE study co-ordinator
embrace-study@unimelb.edu.au
+613903 53027
Time Frame
Start Date: 2025-08
Estimated Completion Date: 2029-03
Participants
Target number of participants: 180
Treatments
Active_comparator: Surgery group
Anterior cruciate ligament reconstruction surgery, undertaken within eight weeks of randomisation, and followed by 12 months of physiotherapist-supervised rehabilitation.
Experimental: Bracing group
A specialised bracing protocol to facilitate healing of the anterior cruciate ligament, including 4 weeks with the knee braced at 90 degrees, and 12 months of supervised physiotherapy rehabilitation.
Related Therapeutic Areas
Sponsors
Leads: University of Melbourne

This content was sourced from clinicaltrials.gov