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Trial registered on ANZCTR


Registration number
ACTRN12616001463460
Ethics application status
Approved
Date submitted
14/10/2016
Date registered
19/10/2016
Date last updated
19/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Accelerated Rehabilitation After Anterior Cruciate Ligament (ACL) Hamstring Reconstruction
Scientific title
Accelerated Versus Conventional Rehabilitation After Double Bundle Remnant Sparing Anterior Cruciate Ligament (ACL) Hamstring Reconstruction: A Prospective Randomised Controlled Trial
Secondary ID [1] 290338 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament tears 300610 0
Condition category
Condition code
Musculoskeletal 300459 300459 0 0
Other muscular and skeletal disorders
Injuries and Accidents 300491 300491 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 300492 300492 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 296150 0
Rehabilitation
Intervention code [2] 296160 0
Treatment: Surgery
Comparator / control treatment
Patients randomised to the control treatment will undergo a conservative (CR) rehabilitation protocol, commencing with closed kinetic chain (CKC) exercises, hydrotherapy and stationary cycling at 6 weeks post-surgery. At 4 months post-surgery, they will 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.
Control group
Active

Outcomes
Primary outcome [1] 299895 0
ACL graft stiffness/laxity evaluated as side to side difference (ssd) in anterior translation of the operated knee versus the native contra-lateral knee, using the KT-1000 arthrometer.
Timepoint [1] 299895 0
24 months post-surgery
Secondary outcome [1] 328416 0
Graft re-rupture assessed via Magentic Resonance Imaging
Timepoint [1] 328416 0
24 months post-surgery
Secondary outcome [2] 328417 0
Time taken to return to sport (Level 1, 2 and 3 sports) – this will be reported via a previously developed ‘ACL Recovery Score’ that evaluates the time taken to return to common daily activities and sports activities. For sport return, this is classified as either Level 1 (i.e. golf, cricket, tennis), Level 2 (i.e. squash, basketball, netball) or Level 3 (i.e. football, rugby, soccer, hockey) sports.
Timepoint [2] 328417 0
6, 12 and 24 months post-surgery
Secondary outcome [3] 328418 0
Isokinetic maximal knee extensor strength using an isokinetic dynamometer (Isosport International, Gepps Cross, South Australia).
Timepoint [3] 328418 0
6, 12 and 24 months post-surgery
Secondary outcome [4] 328480 0
Knee re-injury rate
Timepoint [4] 328480 0
6, 12 and 24 months (or anytime throughout the initial 24 month post-operative period), assessed via clinical examination and MRI if required
Secondary outcome [5] 328542 0
Knee Outcome Survey
Timepoint [5] 328542 0
6, 12 and 24 months post-surgery
Secondary outcome [6] 328543 0
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [6] 328543 0
6, 12 and 24 months post-surgery
Secondary outcome [7] 328544 0
Modified Cincinnati Knee Rating System Questionnaire
Timepoint [7] 328544 0
6, 12 and 24 months post-surgery
Secondary outcome [8] 328545 0
Lysholm Knee Score
Timepoint [8] 328545 0
6, 12 and 24 months post-surgery
Secondary outcome [9] 328546 0
Tegner Activity Score
Timepoint [9] 328546 0
6, 12 and 24 months post-surgery
Secondary outcome [10] 328547 0
Short Form Health Survey (SF-36)
Timepoint [10] 328547 0
6, 12 and 24 months post-surgery
Secondary outcome [11] 328548 0
International Knee Documentation Committee (IKDC) Subjective Knee Form
Timepoint [11] 328548 0
6, 12 and 24 months post-surgery

Eligibility
Key inclusion criteria
1. The individual has reached skeletal maturity (closure of the epiphyses, generally 14-16 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.
Minimum age
14 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A different investigator to the investigator who recruits participants conducts participant randomization and allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization process involves web-based random number generation based on atmospheric variance – arguably more random than computer algorithm random sequencing (see www.random.org). For each participant this website will generate a random number. Participants for whom an odd number is generated will go to the conservative rehabilitation group, while participants for whom an even number is generated will go to the accelerated rehabilitation group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
For this RCT, a priori power calculation has been determined based on our primary outcome variable, which is graft stiffness/laxity evaluated as side to side difference (ssd) in anterior translation of the operated knee versus the native contra-lateral knee. Graft stiffness will be evaluated via the KT-1000 arthrometer at 6, 12 and 24 months post-surgery. The KT-100 has demonstrated validity and is used routinely in the evaluation of ACL tears and following ACLR. Based on the recommendations of Cohen, which indicates that for an anticipated large effect size (d = 0.80) in the primary outcome variable (anterior translation in mm), a total of 36 patients (18 in each group) are required to reveal differences at the 5% significance level, with 80% power. Therefore, 40 patients (20 per group) will be recruited to allow for attrition.

In order to analyze the primary endpoint, a series of repeated measures ANCOVAs will be used to investigate differences in graft laxity between the two patient groups. A Tukeys post-hoc statistic will be used to determine time-points at which the two groups differ, given any significant main effects. Statistical analysis will be performed using SPSS software (SPSS, Version 11.5, SPSS Inc., USA). A series of repeated measures ANCOVAs will be used to investigate differences in these secondary measures between the two patient groups, as per the above statistical procedures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6828 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 14492 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 294720 0
Commercial sector/Industry
Name [1] 294720 0
Smith & Nephew Surgical Pty Ltd
Address [1] 294720 0
85 Waterloo Road, North Ryde NSW Australia 2113
Country [1] 294720 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Smith & Nephew Surgical Pty Ltd
Address
Smith & Nephew Surgical Pty Ltd
85 Waterloo Road
North Ryde, NSW, Australia, 2113
Country
Australia
Secondary sponsor category [1] 293564 0
None
Name [1] 293564 0
Address [1] 293564 0
Country [1] 293564 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296139 0
Hollywood Private Hospital
Ethics committee address [1] 296139 0
Monash Avenue, Nedlands, Western Australia, 6009
Ethics committee country [1] 296139 0
Australia
Date submitted for ethics approval [1] 296139 0
16/03/2015
Approval date [1] 296139 0
26/05/2015
Ethics approval number [1] 296139 0
HPH414

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69702 0
Dr Peter Annear
Address 69702 0
Perth Orthopaedic and Sports Medicine Centre
31 Outram Street
West Perth WA 6005
Country 69702 0
Australia
Phone 69702 0
+61 8 9212 4200
Fax 69702 0
Email 69702 0
peterannear@perthortho.com.au
Contact person for public queries
Name 69703 0
Dr Jay Ebert
Address 69703 0
The School of Sport Science, Exercise and Health
The University of Western Australia
35 Stirling Highway, Crawley, 6009, Western Australia
Country 69703 0
Australia
Phone 69703 0
+61 8 9386 9961
Fax 69703 0
Email 69703 0
jay.ebert@uwa.edu.au
Contact person for scientific queries
Name 69704 0
Dr Jay Ebert
Address 69704 0
The School of Sport Science, Exercise and Health
The University of Western Australia
35 Stirling Highway, Crawley, 6009, Western Australia
Country 69704 0
Australia
Phone 69704 0
+61 8 9386 9961
Fax 69704 0
Email 69704 0
jay.ebert@uwa.edu.au

No information has been provided regarding IPD availability
Summary results
No Results