Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture (NCT06956339) | Clinical Trial Compass
RecruitingNot Applicable
Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture
Australia180 participantsStarted 2025-08-07
Plain-language 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.
Who can participate
Age range
16 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 and/or alterative treatment:
i) Loose body ii) Unstable osteochondral defect iii) Intra-articular fracture that extends into the articular surface and requires reduction iv) Displaced and/or unstable meniscal tear v) Grade 2 and 3 posterolateral corner injury vi) High-grade medial collateral ligament (MCL) injury that requires treatment with a knee brace and/or surgery vii) Posterior cruciate ligament (PCL) injury (partial discontinuity with some preserved fibers or complete disruption)
* Severe disruption of ACL tissue visible on MRI:
i) Gap distance ≥8mm and ≥ 25% of tissue displaced outside of intercondylar notch ii) Gap distance ≥8mm and ≥ 25% of femoral footprint avulsed iii) ≥ 25% of femoral footprint avulsed and ≥ 25% of tissue displaced outside of intercondylar notch iv) Complete femoral or tibial avulsion
* Co…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Knee pain, symptoms, sport and recreational function, and knee-related quality of life as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS4) self-reported questionnaire.
Timeframe: Baseline and 6-, 12- and 18-months after randomisation