Clinical trial NCT06956339: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: anterior cruciate ligament
cross bracing
ACL healing
ACL
ACL reconstruction surgery
Lead sponsor: University of Melbourne
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 180
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: Baseline and 6-, 12- and 18-months after randomisation
Secondary outcomes:
measure: Anterior cruciate ligament-related quality of life as assessed by the Anterior Cruciate Ligament Quality of Life Scale (ACLQOL) self-reported questionnaire
timeFrame: Baseline and 6-, 12- and 18-months after randomisation
measure: Return to pre-injury level of sport or activity as measured by the Tegner Activity Scale self-reported questionnaire
timeFrame: 6, 12 and 18 months after randomisation
measure: The number and proportion of participants satisfied with their knee function, where satisfaction with current knee function is assessed using a single item question
timeFrame: 6, 12 and 18 months after randomisation
measure: Knee pain assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale, with a score range from 0 (worst) to 100 (best).
timeFrame: Baseline and 6-, 12- and 18-months after randomisation
measure: Knee symptoms assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms Subscale, with a score range from 0 (worst) to 100 (best).
timeFrame: Baseline and 6-, 12- and 18-months after randomisation
measure: 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).
timeFrame: Baseline and 6-, 12- and 18-months after randomisation
measure: 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).
timeFrame: Baseline and 6-, 12- and 18-months after randomisation
measure: Number of participants reporting with least one related serious adverse event during their 18-month period in the trial
timeFrame: From randomisation until the collection of the final data at 18 months
measure: Number and proportion of participants reporting one or more anterior cruciate ligament re-rupture or graft rupture confirmed by MRI or arthroscopy
timeFrame: From randomisation until the collection of the final self-reported data at 18 months
measure: Knee instability assessed by self-report of episodes of giving way of the anterior cruciate ligament injured knee
timeFrame: From randomisation until the collection of final data at 18 months
measure: 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).
timeFrame: Baseline and 6-, 12- and 18-months after randomisation
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The University of Melbourne
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Stephanie Filbay
role: PRINCIPAL_INVESTIGATOR
References: