Brace vs. surgery: can a simple knee brace heal a torn ACL?
NCT ID NCT06956339
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two ways to treat a torn anterior cruciate ligament (ACL): a new bracing protocol (wearing a knee brace for 12 weeks plus physiotherapy) versus early surgery. 180 people aged 16-40 with a recent ACL tear will be randomly assigned to one of the two groups. Researchers will track knee pain, function, and quality of life over 18 months to see which approach is more effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- knee brace and physiotherapy
- What this could lead to
- If the bracing protocol works, it could offer a non-surgical option for ACL tears, helping people avoid surgery and its recovery challenges.
- What could go wrong
- This is a relatively small trial (180 people) and the bracing requires 12 weeks in a brace plus many physio visits. It may not work for everyone, and surgery remains the standard treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Melbourne
RECRUITINGMelbourne, Victoria, 3010, Australia
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