Cross bracing versus early ACL reconstruction for recent ACL rupture

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

This will try whether a 12-week cross bracing program plus supervised physiotherapy helps people aged 16–40 with a recent complete ACL tear more than early ACL reconstruction surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 16 Years to 40 Years
• Sex: All
• Sponsor: University of Melbourne (other)
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT06956339 on ClinicalTrials.gov

What this trial studies

The EMBRACE trial randomizes 180 people with recent MRI-confirmed complete ACL ruptures to either a Cross Bracing Protocol or early ACL reconstruction surgery. The bracing arm wears a knee brace for 12 weeks, sees a sports doctor, and receives 23 supervised physiotherapy visits over 12 months with MRI scans at 3 and 18 months; the surgery arm receives early ACL reconstruction. Primary outcomes include knee pain, symptoms, function, quality of life, and health economic (cost-effectiveness) measures. The trial is led by the University of Melbourne and conducted across multiple Australian sites in people who were moderately active before their injury.

Who should consider this trial

Good fit: Ideal candidates are 16–40 years old with an acute, MRI-confirmed complete ACL rupture who were moderately active before injury and can attend regular physiotherapy and follow-up visits.

Not a fit: Patients with concomitant knee injuries that require surgical treatment (for example displaced meniscal tears, unstable osteochondral defects, intra-articular fractures, or high-grade MCL/posterolateral corner injuries) or those unable to attend follow-up visits are unlikely to benefit from the bracing pathway.

Why it matters

Potential benefit: If successful, this approach could provide an effective non-surgical option that reduces the need for early ACL reconstruction and lowers recovery burden and costs.

How similar studies have performed: Some previous trials of structured non-operative rehabilitation versus reconstruction have reported comparable outcomes in selected patients, but the specific Cross Bracing Protocol is novel and has not been tested in large randomized trials.

Eligibility criteria

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
* 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);
* Open growth plate of the femur and/or tibia visible on MRI;
* Past history of ACL injury on the ACL-injured knee;
* Past history of any surgery on ACL-injured knee;
* Breastfeeding, pregnancy or planned pregnancy within the first 12 weeks of the trial;
* 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.

Where this trial is running

Melbourne, Victoria

• The University of Melbourne — Melbourne, Victoria, Australia (RECRUITING)

Study contacts

• Principal investigator: Stephanie Filbay — University of Melbourne
• Study coordinator: EMBRACE study co-ordinator

Conditions: Anterior Cruciate Ligament Rupture, anterior cruciate ligament, cross bracing, ACL healing, ACL, ACL reconstruction surgery