Actively Recruiting
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
Led by University of Melbourne · Updated on 2026-05-07
180
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief 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
- 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 ACL reconstruction surgery
You will not qualify if you...
- Have not completed the baseline questionnaire within 16 days of their initial ACL injury
- Inability to read and speak English
- Concomitant knee injury diagnosed on MRI that requires surgical opinion or alternative treatment, such as loose bodies, unstable osteochondral defects, intra-articular fractures, displaced meniscal tears, posterolateral corner injuries grade 2 or 3, high-grade medial collateral ligament injury, or posterior cruciate ligament injury
- Severe disruption of ACL tissue visible on MRI, including large gap distances or complete avulsions
- Concomitant patellofemoral joint dislocation or history of recurrent patellofemoral instability
- Self-reported episodes of knee instability causing increased pain, swelling, and reduced function without recent MRI
- Open growth plates visible on MRI
- Past history of ACL injury or surgery on the injured knee
- Breastfeeding, pregnancy, or planned pregnancy within first 12 weeks of the trial
- Health conditions or medications contraindicating ACL reconstruction, the bracing protocol, or anticoagulant use, including deep vein thrombosis, hypercoagulable diseases, severe kidney or liver impairment, bleeding disorders, significant cardiovascular disease, infections, inflammatory arthritis, immunosuppressive illnesses, connective tissue disorders, systemic steroid use, or substance addiction
- Body mass index 40 kg/m2 or higher except in competitive athletes
- Other significant medical conditions requiring close monitoring while anticoagulated, such as rheumatoid arthritis or diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive either early anterior cruciate ligament reconstruction surgery followed by physiotherapist-supervised rehabilitation for 12 months, or a specialised bracing protocol with progressive knee range adjustments over 12 weeks combined with 12 months of supervised physiotherapy rehabilitation.
Multiple physiotherapy visits over 12 months; surgery group also includes routine preoperative and post-operative care visits
Duration - Up to 6 months after treatment completion (total 18 months from randomisation)
Participants are followed up to assess knee function, symptoms, quality of life, and any adverse events up to 18 months after randomisation.
Assessments at 6, 12, and 18 months after randomisation
Trial Site Locations
Total: 1 location
1
The University of Melbourne
Melbourne, Victoria, Australia, 3010
Actively Recruiting
Research Team
E
EMBRACE study co-ordinator
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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