Anterior Cruciate Ligament RuptureEMBRACENCT06956339
Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture
A study testing Early anterior cruciate ligament surgery and Novel bracing protocol in people with Anterior Cruciate Ligament Rupture, run by University of Melbourne at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Early anterior cruciate ligament surgery and Novel bracing protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Aug 2025to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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:
- 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:
- 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
Show all 14Show fewer
- 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:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
The University of Melbourne
Melbourne, Victoria, 3010
EMBRACE study co-ordinator, +613903 53027, embrace-study@unimelb.edu.au
About this study
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
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?
Read more
180 people across five Australian cities, with a recent ACL injury, will be randomly allocated to one of two treatments.
- 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
- 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.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Early anterior cruciate ligament surgery, Novel bracing protocol
- Keywords
- anterior cruciate ligament, cross bracing, ACL healing, ACL, ACL reconstruction surgery
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early anterior cruciate ligament surgeryProcedure or 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.
Novel bracing protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery group | Active comparator | Anterior cruciate ligament reconstruction surgery, undertaken within eight weeks of randomisation, and followed by 12 months of physiotherapist-supervised rehabilitation. Receives: Procedure: Early anterior cruciate ligament surgery |
| Bracing group | Experimental | 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. Receives: Other: Novel bracing protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
An average of the four subscale scores is used for the overall KOOS4 score, from 0 (worst) to 100 (best).
Measured: Baseline and 6-, 12- and 18-months after randomisation
Secondary outcomes (11)
Anterior cruciate ligament-related quality of life as assessed by the Anterior Cruciate Ligament Quality of Life Scale (ACLQOL) self-reported questionnaire
Overall score ranges from 0 (worst) to 100 (best).
Measured: 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
The Tegner Activity Scale is a self-reported single item questionnaire scored on an 11-item scale (0 (lower activity) -10 (higher activity). The number and proportion of participants who have returned to their same or higher level of sport or activity will be reported.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: Baseline and 6-, 12- and 18-months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start7 Aug 2025
- Primary completionNov 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Filbay, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956339
- Sponsor's protocol ID
- EMBRACE 31092
- Acronym
- EMBRACE
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share all deidentified data that support published results of the trial. Additional data that have not been published will be withheld until at least six months after publication. Data will be made available as required for specific, approved analyses, where these comply with our ethical requirements and the planned secondary analysis is of sufficient methodological rigour. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06956339
- Acronym / sponsor ID
- EMBRACE / EMBRACE 31092
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- anterior cruciate ligament, cross bracing, ACL healing, ACL, ACL reconstruction surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery group | Active comparator | Procedure: Early anterior cruciate ligament surgeryAnterior cruciate ligament reconstruction surgery, undertaken within eight weeks of randomisation, and followed by 12 months of physiotherapist-supervised rehabilitation. |
| Bracing group | Experimental | Other: Novel bracing protocolA 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. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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:
- Severe disruption of ACL tissue visible on MRI:
- Concomitant patellofemoral joint dislocation diagnosed on MRI and/or self-reported history of recurrent patellofemoral joint instability or ≥1 patellofemoral joint dislocation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early anterior cruciate ligament surgeryParticipants 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. | Procedure or surgery | Surgery group |
| Novel bracing protocolParticipants 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. | Other | Bracing group |
Primary outcome
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
An average of the four subscale scores is used for the overall KOOS4 score, from 0 (worst) to 100 (best).
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. We will share all deidentified data that support published results of the trial. Additional data that have not been published will be withheld until at least six months after publication. Data will be made available as required for specific, approved analyses, where these comply with our ethical requirements and the planned secondary analysis is of sufficient methodological rigour. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Filbay principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early anterior cruciate ligament surgery and Novel bracing protocol in people with Anterior Cruciate Ligament Rupture, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EMBRACE study co-ordinator (+613903 53027, embrace-study@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Baseline and 6-, 12- and 18-months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.