Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture

NCT ID: NCT06956339

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2029-03-31

Brief 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.

Conditions

Anterior Cruciate Ligament Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgery group

Anterior cruciate ligament reconstruction surgery, undertaken within eight weeks of randomisation, and followed by 12 months of physiotherapist-supervised rehabilitation.

Group Type: ACTIVE_COMPARATOR

Early anterior cruciate ligament surgery

Intervention Type: PROCEDURE

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.

Bracing group

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.

Group Type: EXPERIMENTAL

Novel bracing protocol

Intervention Type: OTHER

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.

Interventions

Early anterior cruciate ligament surgery

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.

Intervention Type: PROCEDURE

Novel bracing protocol

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Melbourne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Filbay

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Locations

The University of Melbourne

Melbourne, Victoria, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

EMBRACE study co-ordinator

Role: CONTACT

embrace-study@unimelb.edu.au

+613903 53027

Facility Contacts

EMBRACE study co-ordinator

Role: primary

embrace-study@unimelb.edu.au

+613903 53027

Other Identifiers

EMBRACE 31092

Identifier Type: -

Identifier Source: org_study_id