Actively Recruiting
Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture
Led by University of Melbourne · Updated on 2026-05-07
180
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 16 to 40 years
- Primary and acute complete ACL rupture confirmed by MRI
- Moderately active before injury (score 5 to 10 on Tegner Activity Scale)
- Willing and able to give informed consent and fully participate
- Willing and able to cover out-of-pocket costs for ACL reconstruction surgery
You will not qualify if you...
- Did not complete baseline questionnaire within 16 days of ACL injury
- Unable to read and speak English
- Additional knee injuries requiring surgery or alternative treatment (loose bodies, unstable osteochondral defects, intra-articular fractures, displaced meniscal tears, grade 2 or 3 posterolateral corner injuries, high-grade MCL injuries needing brace or surgery, PCL injuries)
- Severe ACL tissue disruption visible on MRI (large gap distances, avulsions)
- Patellofemoral joint dislocation or recurrent instability
- Episodes of knee instability causing increased pain and swelling without new MRI
- Open growth plates in femur or tibia
- Past ACL injury or surgery on the injured knee
- Pregnant, breastfeeding, or planning pregnancy within 12 weeks
- Health conditions or medications contraindicating surgery, bracing, or anticoagulant use (including DVT, bleeding disorders, severe organ impairment, certain medications, infections, inflammatory arthritis, osteoarthritis, immunosuppressive illnesses, connective tissue disorders, steroid use, substance addiction)
- Body mass index over 40 kg/m2 except competitive athletes
- Known cardiovascular or chronic respiratory diseases except controlled asthma
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Melbourne
Melbourne, Victoria, Australia, 3010
Actively Recruiting
Research Team
E
EMBRACE study co-ordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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