Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture

NARecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

March 31, 2029

Conditions
Anterior Cruciate Ligament Rupture
Interventions
PROCEDURE

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

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."

Trial Locations (1)

3010

RECRUITING

The University of Melbourne, Melbourne

All Listed Sponsors
lead

University of Melbourne

OTHER

NCT06956339 - Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture | Biotech Hunter | Biotech Hunter