Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture

Official title

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

Overview

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.

Interventions

• Procedure 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 su
• Other 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 a

Primary outcome measures

• 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. [Time frame: Baseline and 6-, 12- and 18-months after randomisation]

Secondary outcome measures (11)

• Anterior cruciate ligament-related quality of life as assessed by the Anterior Cruciate Ligament Quality of Life Scale (ACLQOL) self-reported questionnaire [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 [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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Australia · 1 center

• The University of Melbourne — Melbourne

Identifiers

NCT: NCT06956339 · EMBRACE 31092

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗