Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-40
SponsorUniversity of Melbourne

About this 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?

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

Qualifiers

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;

Disqualifiers

Have not completed the baseline questionnaire within 16 days of their initial ACL injury;

Inability to read and speak English

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);

Trial design

Treatments tested in this trial

  • Early anterior cruciate ligament surgery
  • Novel bracing protocol

Treatment groups

180 Participants
are divided into 2 treatment groups

Sponsors and collaborators