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Accelerated Rehabilitation After Anterior Cruciate Ligament (ACL) Hamstring Reconstruction

Accelerated Versus Conventional Rehabilitation After Double Bundle Remnant Sparing Anterior Cruciate Ligament (ACL) Hamstring Reconstruction: A Prospective Randomised Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001463460
Enrollment
44
Registered
2016-10-19
Start date
2015-12-08
Completion date
2018-04-15
Last updated
2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a prospective randomized controlled trial (RCT) investigating the graft stiffness of a Double Bundle (DB) remnant sparing Anterior Cruciate Ligament Reconstruction. The patients receiving this graft configuration will be randomized to either an accelerated rehabilitation program or a conventional rehabilitation program. Six months and one and two year graft laxity measures will be used as the primary outcome measure of the graft stiffness and its response to two forms of rehabilitation loads. Our overall hypothesis is that accelerated rehabilitation culminating in a return to sport at 6 months post-surgery will have no adverse effects on the graft laxity after ACLR, evaluated primarily by graft laxity measures at 1 and 2 years and secondarily by the time taken to return to sport, patient satisfaction, validated functional scores and patient-reported outcome (PRO) measures.

Interventions

All patients will undergo double bundle remnant sparing anterior cruciate ligament reconstruction (ACLR). This is the preferred operative technique of the orthopaedic surgeon involved in this research. After surgery, all patients will be initially placed in a resting extension splint (removed only to undertake exercises) for 2 weeks allowing crutch weight bearing (WB) as tolerated. In-patient exercises will be undertaken by a physiotherapist in hospital once prior to discharge, which will be th

All patients will undergo double bundle remnant sparing anterior cruciate ligament reconstruction (ACLR). This is the preferred operative technique of the orthopaedic surgeon involved in this research. After surgery, all patients will be initially placed in a resting extension splint (removed only to undertake exercises) for 2 weeks allowing crutch weight bearing (WB) as tolerated. In-patient exercises will be undertaken by a physiotherapist in hospital once prior to discharge, which will be the next day (i.e. generally only one night spent in hospital). These exercises will then be undertaken by all patients unsupervised 2-3 times per day at home upon hospital discharge, and up until the time of their first scheduled out-patient rehabilitation visit. These early in-patient exercises will focus on regaining knee range of motion (ROM), patella mobility and pain/swelling reduction. Patients are allowed to cease the use of the brace once their knee effusion had resolved. For out-patient rehabilitation, patients will attend the Hollywood Functional Rehabilitation Clinic for post-operative out-patient rehabilitation, and appropriate monitoring of their program and ensuring adherence to the protocol. Patients will attend the clinic for one supervised session per week (of 1-2 hours duration) for the first 11 weeks (weeks 1-12), and then once every two weeks between 12 weeks and 6 months. In addition to their supervised sessions, all patients will undertake a structured home-based supplemental program an additional 3-4 times per week, which which evolve as time permits. The supervised sessions will be undertaking by one (of two) Accredited Exercise Physiologists (AEPs), each with more than 10 years of clinical experience and with a clinical and research interest in ACLR. Based on their pre-operative randomisation (conservative or accelerated rehabilitation), they will undergo one of two progressive rehabilitation programs as follows. Patients randomised to the conservative (CR) rehabilitation protocol will commence closed kinetic chain (CKC) exercises, hydrotherapy and stationary cycling at 6 weeks post-surgery, following clearance to do so by the primary surgeon. At 4 months post-surgery, a structured strengthening program inclusive of these exercises will continue, though they will also commence jogging, progressing to change of direction exercise and sport specific exercises by 6 months. They will be permitted to commence full sport and pivoting activities at 9-12 months post-operatively. Patients randomised to the accelerated (AR) rehabilitation protocol will initiate the majority of exercises at an earlier post-operative time line. CKC exercises, hydrotherapy and stationary cycling will begin at 3 weeks post-surgery, jogging at 2 months, agility activities at 4 months and a planned return to sport by 6 months post-surgery. While specific exercises and activities will indeed be undertaken by both groups eventually through their rehabilitation timeline, the 'timing' and 'introduction' of certain activities and rehabilitation exercises is the only variable that will differ between these two groups. A weekly monitoring activity and rehabilitation plan will be undertaken for all patients, in order to best attempt to maintain compliance to the respective interventions. In addition to this activity log which will be discussed with patients each week, email correspondence weekly will also permit monitoring.

Sponsors

Smith & Nephew Surgical Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
16 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

1. The individual has reached skeletal maturity (closure of the epiphyses, generally 16 years of age) and under the age of 45 years. 2. The individual clinically qualifies for ACL reconstructive surgery based on clinical examination and MRI 3. The individual has sustained the ACL tear within the last four months 4. The individual is not currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol/substance abuse.

Exclusion criteria

1. The individual is unable or unwilling to sign the Patient Informed Consent, specific to this study, and approved by the Institutional Ethics Review Board 2. The individual is unable or unwilling to follow the designated rehabilitation protocol 3. The individual is classified as morbidly obese (>40 BMI) 4. The individual is skeletally immature.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026