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Compares treatment options for Anterior Cruciate Ligament Rupture
Official title Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture
ClinicalTrials.gov ID: NCT06956339
What this study is testing
- What it's testing
- 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?
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 40
You may be able to join if
- 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.
You likely can't join if
- 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...
- Severe disruption of ACL tissue visible on MRI: i) Gap distance ≥8mm and ≥ 25% of tissue displaced outside of intercondylar notch ii) Gap distance...
- Concomitant patellofemoral joint dislocation diagnosed on MRI and/or self-reported history of recurrent patellofemoral joint instability or ≥1...
- Self-reported episode of instability (i.e. 'giving way') since initial MRI that resulted in increased pain, swelling and reduced function (without a...
See the full eligibility 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.
- 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...
- 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...
- 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)...
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.