An interventional study of Early anterior cruciate ligament surgery and Novel bracing protocol in Anterior Cruciate Ligament Rupture, sponsored by University of Melbourne. Recruiting at 1 site in Australia. Open to participants aged 16 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by University of Melbourne · Not applicable, Interventional, and Treatment
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.
Cross Bracing Protocol
People who are allocated to the bracing treatment will:
People who are allocated to the surgery group will:
All participants will:
511 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 163 are open to participants now.
This study's planned enrollment of 180 is above the median of 56 across 372 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →University of Melbourne is the lead sponsor of 84 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Health conditions/medications that are contraindications for ACLR, CBP and/or use of anticoagulant (rivaroxaban) medication:
i) Current deep vein thrombosis (DVT); ii) Past history of DVT and/or pulmonary embolism; iii) Diagnosed hypercoagulable disease (e.g., Protein C and Protein S deficiency, Factor 5 Leiden); iv) Significant renal/hepatic impairment (creatinine clearance \<15mL/min, Child-Pugh score 10-15 (Class C)); v) Restless Legs Syndrome; vi) Current use of contraindicated medication (such as other anticoagulants, antiviral or oral anti-fungal medications); vii) Clinically significant active and/or recent bleeding (e.g., gastrointestinal, intracranial or haematuria); viii) At increased risk of clinically significant bleeding (e.g., significant inherited bleeding disorders, uncontrolled high blood pressure); ix) Other conditions requiring significant medical monitoring while anticoagulated, such as rheumatoid arthritis, type I or type II diabetes, autoimmune diseases; x) Self-reported body mass index (BMI) ≥40kg/m2, except in competitive athletes (defined as a pre-injury Tegner Activity Scale score of 7-10 and/or undertakes strength training/weightlifting two or more times per week); xi) Any known cardiovascular disease (history of stroke, coronary vascular disease); xii) Chronic obstructive pulmonary disease and/or chronic respiratory disease, except for controlled asthma; xiii) Acute infection of the knee or affected limb; xiv) Inflammatory arthropathy/arthritis; xv) knee osteoarthritis in the ACL-injured knee (assessed on acute knee MRI, defined as focal partial thickness cartilage loss or greater (at least ACLOAS grade 2 cartilage lesion2626) plus one or more definite osteophyte (at least ACLOAS grade 2 osteophyte26 xvi) Concurrent immunosuppressive illness (e.g., AIDS, cancer) and/or immunosuppressant usage; xvii) Connective tissue disorders (such as Ehlers-Danlos syndrome); xviii) Current systemic steroid usage; xix) Intravenous drug users and/or substance addiction.
Anterior cruciate ligament reconstruction surgery, undertaken within eight weeks of randomisation, and followed by 12 months of physiotherapist-supervised rehabilitation.
Procedure: Early anterior cruciate ligament surgery
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.
Other: Novel bracing protocol
Participants 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.
Participants 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).
Time frame: Baseline and 6-, 12- and 18-months after randomisation
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).
Time frame: Baseline and 6-, 12- and 18-months after randomisation
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.
Time frame: 6, 12 and 18 months after randomisation
The number and proportion of participants satisfied with their knee function, where satisfaction with current knee function is assessed using a single item question
Time frame: 6, 12 and 18 months after randomisation
Knee pain assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale, with a score range from 0 (worst) to 100 (best).
Time frame: Baseline and 6-, 12- and 18-months after randomisation
Knee symptoms assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms Subscale, with a score range from 0 (worst) to 100 (best).
Time frame: Baseline and 6-, 12- and 18-months after randomisation
Knee-related sport and recreational function assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) Sports and Recreational Activities Subscale, with a score range from 0 (worst) to 100 (best).
Time frame: Baseline and 6-, 12- and 18-months after randomisation
Knee-related quality of life assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) Quality of Life Subscale, with a score range from 0 (worst) to 100 (best).
Time frame: Baseline and 6-, 12- and 18-months after randomisation
Number of participants reporting with least one related serious adverse event during their 18-month period in the trial
Time frame: From randomisation until the collection of the final data at 18 months
Number and proportion of participants reporting one or more anterior cruciate ligament re-rupture or graft rupture confirmed by MRI or arthroscopy
Time frame: From randomisation until the collection of the final self-reported data at 18 months
Knee instability assessed by self-report of episodes of giving way of the anterior cruciate ligament injured knee
Time frame: From randomisation until the collection of final data at 18 months
Fear of reinjury assessed using self-report of item 31 from the Anterior Cruciate Ligament Quality of Life Scale, ranging from 0 (extremely fearful) to 100 (no fear at all).
Time frame: Baseline and 6-, 12- and 18-months after randomisation
Plan to share: Yes — We will share all deidentified data that support published results of the trial. Additional data that have not been published will be withheld until at least six months after publication. Data will be made available as required for specific, approved analyses, where these comply with our ethical requirements and the planned secondary analysis is of sufficient methodological rigour. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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University of Melbourne