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.
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;
Have not completed the baseline questionnaire within 16 days of their initial ACL injury;
Inability to read and speak English
Concomitant patellofemoral joint dislocation diagnosed on MRI and/or self-reported history of recurrent patellofemoral joint instability or ≥1 patellofemoral joint dislocation;
Self-reported episode of instability (i.e. 'giving way') since initial MRI that resulted in increased pain, swelling and reduced function (without a subsequent MRI to re-determine eligibility);
Parallel
Early anterior cruciate ligament surgery
Procedure/SurgeryParticipants 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.
Novel bracing protocol
Other interventionParticipants 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.
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.
An average of the four subscale scores is used for the overall KOOS4 score, from 0 (worst) to 100 (best).
Anterior cruciate ligament-related quality of life as assessed by the Anterior Cruciate Ligament Quality of Life Scale (ACLQOL) self-reported questionnaire
Overall score ranges from 0 (worst) to 100 (best).
Return to pre-injury level of sport or activity as measured by the Tegner Activity Scale self-reported questionnaire
The Tegner Activity Scale is a self-reported single item questionnaire scored on an 11-item scale (0 (lower activity) -10 (higher activity). The number and proportion of participants who have returned to their same or higher level of sport or activity will be reported.
The number and proportion of participants satisfied with their knee function, where satisfaction with current knee function is assessed using a single item question
Knee pain assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale, with a score range from 0 (worst) to 100 (best).
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