Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001382268
Ethics application status
Approved
Date submitted
13/08/2018
Date registered
16/08/2018
Date last updated
14/08/2019
Date data sharing statement initially provided
14/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does preoperative anterior cruciate ligament rehabilitation produce superior outcomes before and after reconstructive surgery compared to current care
Scientific title
Preoperative anterior cruciate ligament rehabilitation compared to current care
Secondary ID [1] 295784 0
Nil
Universal Trial Number (UTN)
U1111-1214-3521
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament rupture / tears

 309204 0
Condition category
Condition code
Musculoskeletal 308077 308077 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 308078 308078 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who satisfy eligibility criteria of a primary unilateral anterior cruciate ligament (ACL) rupture awaiting surgery are referred by their Surgeon to consider participation in preoperative rehabilitation. After undergoing baseline testing consisting of validated isokinetic strength testing of the quadriceps, hop tests (6m and maximal distance), and self-reported scales (KOOS, Tegner, Marx) consented participants are randomised into either the intervention (Group 1) or current care (Group 2) cohort.

The intervention cohort complete a 6-week supervised preoperative rehabilitation protocol, and Group 2 continue with their usual care and preparation for 6 weeks while awaiting surgical reconstruction. The intervention methodology consists of progressive overloading exercise focused on quadriceps strength, and is delivered by a specifically qualified physiotherapist twice per week. After completing the respective 6 week preoperative phases participants are re-tested, and then undergo ACL reconstruction. All participants can receive post-operative rehabilitation as guided by their Surgeon and return for final assessment 12 weeks post-surgically.
Post-operative rehabilitation is unrestricted over the 12-week reassessment timeframe as evidence suggests that irrespective of the type of post-operative rehabilitation protocol the critical success factor up to 2 years post surgically is preoperative rehabilitation aimed at optimising quadriceps strength. Therefore, the study design is confined to examining the effectiveness of preoperative rehabilitation, and no constraints or control over post-operative rehabilitation has been given.
After the final assessment, a small number of selected participants from each cohort will be interviewed using a written series of questions related to the experience of undergoing rehabilitation for their ACL injury.
Intervention code [1] 312115 0
Rehabilitation
Comparator / control treatment
Participants randomised to Group 2 or current care will receive the same 6-week timeframe to prepare before reassessment and surgery. The composition or structure of the preoperative phase is not influenced or discouraged, and may include structured physiotherapy or Surgeon lead recommendations. This therefore best represents current care.
Control group
Active

Outcomes
Primary outcome [1] 307072 0
Quadriceps strength (peak torque in Nm) measured with a valid and reliable isokinetic dynamometer (Biodex system 4)
Timepoint [1] 307072 0
Baseline
6 weeks after preoperative rehabilitation
12 weeks after ACL surgical reconstruction
Secondary outcome [1] 350551 0
Single legged hop test battery, which includes timed 6m hop, and hop for distance measured in cm using a standardised method
Timepoint [1] 350551 0
Baseline
6 weeks after preoperative rehabilitation
12 weeks after ACL surgical reconstruction
Secondary outcome [2] 350552 0
Knee Osteoarthritis Outcome Score (KOOS). The 42- item disease specific questionnaire consists of 5 subscales; pain, symptom, quality of life, activity of daily living and sports and recreation
Timepoint [2] 350552 0
Baseline
6 weeks after preoperative rehabilitation
12 weeks after ACL surgical reconstruction
Secondary outcome [3] 350553 0
Tegner activity level scale. The Tegner activity score grades the level of work and sports activities with reference to knee loading where a score of 10 categorises elite level competitive sports, and 0 indicates disability due to the knee
Timepoint [3] 350553 0
Baseline
6 weeks after preoperative rehabilitation
12 weeks after ACL surgical reconstruction
Secondary outcome [4] 350554 0
Marx frequency of activity scale. The Marx tool categorises the frequency of activity with specific reference to running, cutting, decelerating and pivoting activities
Timepoint [4] 350554 0
Baseline
6 weeks after preoperative rehabilitation
12 weeks after ACL surgical reconstruction

Eligibility
Key inclusion criteria
• Diagnosed with a primary unilateral ACL by Surgeon and MRI
• Awaiting reconstructive surgery
• Referred for physiotherapy
• 18-50 years of age
• Injury claim lodged and registered with the ACC
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of significant contralateral knee injury, fracture, full thickness chondral injury,
symptomatic meniscal injury.
• Unable to undertake an exercise programme

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)
Randomisation is completed after baseline testing in those people consented and fully enrolled in the trial. One hundred and twenty opaque and sealed envelopes will be generated and a person independent of the trial will offer the enrolled participant an envelope from a secure box holding all the concealed envelopes. Participants will be randomly assigned into one of two groups
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation is employed by using concealed envelopes, and participant self selection of the concealed envelope
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For this RCT data on 24 mean quadriceps peak torques were summarised using a weighted linear mixed model in an ad hoc meta-analysis to obtain estimates of the mean primary outcome and its variance at 12 weeks, both with and without prehabilitation (Czaplicki, Jarocka, & Walawski, 2015; Eitzen 2010; Willingenburg, McNallay, & Hewett, 2015). In an evenly distributed sample in terms of sex, the difference in means is expected to be approximately 22 Nm in favour of the intervention group, and therefore the detectable difference is set at this value. Therefore to achieve 80% power (p=0.5) to detect a difference of 22Nm, 48 participants will be required for each group. Assuming attrition at 20% over 12 weeks 60 participants will be recruited for each group producing a total cohort of 120 participants.

All statistical analysis will be performed using the Statistical Package for Social Sciences (IBM SPSS). Minimal clinically relevant differences have previously been established, and an alpha level of p < 0.05 will be set as statistically significant. To test the mean difference in the primary and secondary outcomes from the intervention group a two factor repeated measures ANOVA will be used.
The primary outcome is change in quadriceps strength from baseline (T0) to 6 weeks (T1) after prehabilitation, and from baseline to 12 weeks (T2) after reconstructive surgery.. Secondary outcomes consist to single legged hopping, KOOS, Tegner, and Marx scores. For all outcomes mean scores with corresponding standard deviations (SD), and between group contrasts (change scores) with corresponding 95% confidence intervals (95% CI) and p value, will be reported at each endpoint (T0, T1, and T2) for each group KC and CC.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/08/2018
Actual
7/01/2019
Date of last participant enrolment
Anticipated
28/10/2019
Actual
Date of last data collection
Anticipated
24/01/2020
Actual
Sample size
Target
120
Accrual to date
80
Final
Recruitment outside Australia
Country [1] 20752 0
New Zealand
State/province [1] 20752 0
Auckland

Funding & Sponsors
Funding source category [1] 300375 0
Commercial sector/Industry
Name [1] 300375 0
KneeCare Ltd
Country [1] 300375 0
New Zealand
Funding source category [2] 300382 0
Government body
Name [2] 300382 0
The Accident Compensation Corportation
Country [2] 300382 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
90 Akoranga Drive
Northcote
Auckland
0627
Country
New Zealand
Secondary sponsor category [1] 299870 0
Individual
Name [1] 299870 0
Geoff Potts
Address [1] 299870 0
Shore Physio and KneeCare head office
2 Byron Avenue
Takapuna
Auckland
0622
Country [1] 299870 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301186 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 301186 0
Ethics committee country [1] 301186 0
New Zealand
Date submitted for ethics approval [1] 301186 0
20/06/2018
Approval date [1] 301186 0
25/07/2018
Ethics approval number [1] 301186 0
18/STH/127

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86146 0
Prof Duncan Reid
Address 86146 0
Room AG 108,
90 AKoranga Drive
Faculty of Health and Environmental Sciences
AUT University
Private Bag 92006, Auckland, 1142
Country 86146 0
New Zealand
Phone 86146 0
+64(9) 921 9999 Ext 7806 Mob
Fax 86146 0
Email 86146 0
[email protected]
Contact person for public queries
Name 86147 0
Geoff Potts
Address 86147 0
Shore Physio and KneeCare
2 Byron Ave
Takapuna
Auckland
0622
Country 86147 0
New Zealand
Phone 86147 0
+64 9 489 7577
Fax 86147 0
Email 86147 0
[email protected]
Contact person for scientific queries
Name 86148 0
Duncan Reid
Address 86148 0
Room AG 108,
90 AKoranga Drive
Faculty of Health and Environmental Sciences
AUT University
Private Bag 92006, Auckland, 1142
Country 86148 0
New Zealand
Phone 86148 0
+64(9) 921 9999 Ext 7806 Mob
Fax 86148 0
Email 86148 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
only anonymised data will be available including demographic data, and outcome measures of strength, function, and patient reported measures as consent by Ethics.
When will data be available (start and end dates)?
Upon completion of the trial, and for a minimum agree 10 years as outline in Ethics application
Available to whom?
To consented participants, and those involved in the research according to the Ethics application
Available for what types of analyses?
Statistical
How or where can data be obtained?
Directly via the researcher or his supervisors


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.