Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture

Launched by UNIVERSITY OF MELBOURNE · May 1, 2025

Keywords

ClinConnect Summary

The EMBRACE clinical trial is studying how different treatments affect people with a recent tear in their anterior cruciate ligament (ACL), which is a key ligament in the knee. The trial compares two approaches: one group will use a special knee brace and participate in physical therapy, while the other group will have surgery to repair the ligament. The researchers want to find out which method helps reduce knee pain, improves function, and enhances quality of life more effectively and at a lower cost.

To join the trial, participants need to be between 16 and 40 years old, have a complete ACL tear confirmed by an MRI, and have been somewhat active before their injury. Those who participate will be randomly assigned to one of the two treatment groups. Participants in the bracing group will wear a brace for 12 weeks and attend multiple therapy sessions, while those who have surgery will undergo the procedure within eight weeks and also attend therapy sessions afterward. Everyone in the study will complete surveys and have follow-up scans to track their progress over time. This trial is important because it may help determine the best way to treat ACL injuries, which can significantly impact a person's ability to stay active.

Gender

ALL

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) Concurrent immunosuppressive illness (e.g., AIDS, cancer) and/or immunosuppressant usage; xvi) Connective tissue disorders (such as Ehlers-Danlos syndrome); xvii) Current systemic steroid usage; xviii) Intravenous drug users and/or substance addiction.