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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06956339




Registration number
NCT06956339
Ethics application status
Date submitted
1/05/2025
Date registered
4/05/2025

Titles & IDs
Public title
Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture
Scientific 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
Secondary ID [1] 0 0
EMBRACE 31092
Universal Trial Number (UTN)
Trial acronym
EMBRACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate Ligament Rupture 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Early anterior cruciate ligament surgery
Other interventions - Novel bracing protocol

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

Experimental: 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.


Treatment: Surgery: 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.

Other interventions: 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 code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline and 6-, 12- and 18-months after randomisation
Secondary outcome [1] 0 0
Anterior cruciate ligament-related quality of life as assessed by the Anterior Cruciate Ligament Quality of Life Scale (ACLQOL) self-reported questionnaire
Timepoint [1] 0 0
Baseline and 6-, 12- and 18-months after randomisation
Secondary outcome [2] 0 0
Return to pre-injury level of sport or activity as measured by the Tegner Activity Scale self-reported questionnaire
Timepoint [2] 0 0
6, 12 and 18 months after randomisation
Secondary outcome [3] 0 0
The number and proportion of participants satisfied with their knee function, where satisfaction with current knee function is assessed using a single item question
Timepoint [3] 0 0
6, 12 and 18 months after randomisation
Secondary outcome [4] 0 0
Knee pain assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale, with a score range from 0 (worst) to 100 (best).
Timepoint [4] 0 0
Baseline and 6-, 12- and 18-months after randomisation
Secondary outcome [5] 0 0
Knee symptoms assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms Subscale, with a score range from 0 (worst) to 100 (best).
Timepoint [5] 0 0
Baseline and 6-, 12- and 18-months after randomisation
Secondary outcome [6] 0 0
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).
Timepoint [6] 0 0
Baseline and 6-, 12- and 18-months after randomisation
Secondary outcome [7] 0 0
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).
Timepoint [7] 0 0
Baseline and 6-, 12- and 18-months after randomisation
Secondary outcome [8] 0 0
Number of participants reporting with least one related serious adverse event during their 18-month period in the trial
Timepoint [8] 0 0
From randomisation until the collection of the final data at 18 months
Secondary outcome [9] 0 0
Number and proportion of participants reporting one or more anterior cruciate ligament re-rupture or graft rupture confirmed by MRI or arthroscopy
Timepoint [9] 0 0
From randomisation until the collection of the final self-reported data at 18 months
Secondary outcome [10] 0 0
Knee instability assessed by self-report of episodes of giving way of the anterior cruciate ligament injured knee
Timepoint [10] 0 0
From randomisation until the collection of final data at 18 months
Secondary outcome [11] 0 0
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).
Timepoint [11] 0 0
Baseline and 6-, 12- and 18-months after randomisation

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2029
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephanie Filbay
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
EMBRACE study co-ordinator
Address 0 0
Country 0 0
Phone 0 0
+613903 53027
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06956339