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Trial registered on ANZCTR


Registration number
ACTRN12618001902280p
Ethics application status
Submitted, not yet approved
Date submitted
14/11/2018
Date registered
22/11/2018
Date last updated
22/11/2018
Date data sharing statement initially provided
22/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Immediate weight bearing in a functional orthotic brace for the conservative treatment of Achilles Tendon Rupture: A randomised controlled trial
Scientific title
Immediate weight bearing in a functional orthotic brace for the conservative treatment of Achilles Tendon Rupture: A randomised controlled trial
Secondary ID [1] 296594 0
Nil Known
Universal Trial Number (UTN)
U1111-1221-2158
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles Tendon Rupture 310407 0
Condition category
Condition code
Injuries and Accidents 309121 309121 0 0
Other injuries and accidents
Musculoskeletal 309122 309122 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves application of a VACOped boot (Oped Ag Ltd, Germany) and commencement of immediate weight bearing after achilles tendon rupture. The boot will be applied in the orthopaedic clinic at a regional hospital by trained staff members and will be worn continuously for the subsequent 8 weeks. Trial participants will be reviewed every 2 weeks for the duration of time in this orthotic boot.

1. Immediate Weight bearing is weight bearing from the time the orthotic is applied, and as per our inclusion criteria the maximum time after injury to weight bearing in the orthotic will be 72hrs.
2. The boot has a locking function which prevents removal by trial participants. If this lock has been tampered with in order to remove the boot this will become apparent at the clinic appointments.
3. Weight bearing will be complete weight bearing as tolerated. Complete weight bearing will be encouraged as soon as patients are able.
Intervention code [1] 312907 0
Treatment: Devices
Comparator / control treatment
The control group undergoes the current standard treatment protocol in the regional hospital. This involves 4 weeks in equinus cast prior to 4 weeks in a moonboot (SCL) and then 4 weeks in orthotic heel raises. The first 6 weeks of this protocol is non-weight bearing.
Control group
Active

Outcomes
Primary outcome [1] 308099 0
Achilles Tendon Rupture Score (ATRS)
Timepoint [1] 308099 0
assessed at 1 year post injury
Secondary outcome [1] 353950 0
Quality of life - Veterans RAND 12 Item Health Survey (VR-12©)
Timepoint [1] 353950 0
assessed at 3, 6 and 12 months post injury
Secondary outcome [2] 354031 0
ATRS
Timepoint [2] 354031 0
assessed at 3 and 6 months post injury
Secondary outcome [3] 354039 0
Re-rupture rate - measured by study specific questionnaire.
Timepoint [3] 354039 0
assessed at 3, 6 and 12 months post injury
Secondary outcome [4] 354040 0
Time taken to return to work - measured by study specific questionnaire.
Timepoint [4] 354040 0
assessed at 3, 6 and 12 months post injury
Secondary outcome [5] 354202 0
Time taken to return to Sport - measured by study specific questionnaire.
Timepoint [5] 354202 0
assessed at 3, 6 and 12 months post injury

Eligibility
Key inclusion criteria
Presenting within 72hrs of injury
Isolated unilateral injury
Closed injury
Aged 16 or older
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

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)
patients will be randomly allocated to the weight bearing or non-weight bearing groups on a 1:1 basis via the use of pre-prepared opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
the primary outcome measure for this study is the ATRS. The minimum clinically significant difference we have chosen for the ATRS for this study is 10. The original ATRS validation study determined a standard deviation of 21.44. With an alpha power of 0.05 and a power of 80% the minimum sample size has been calculated as 72 per treatment arm. To ensure the results are not affected by patients lost to follow up a 20% margin above this number has been selected. Therefore, the aim will be to have 86 patients randomized to each treatment arm in order to provide sufficient power to detect the minimum clinically significant difference

Baseline characteristics will be summarized and compared between the two groups. Analysis of primary outcome measures will be completed on an intention-to-treat basis. The main results reported will include differences in ATRS and HRQOL scores at 3, 6, and 12 months. Complications rates will be recorded and compared at 12 months. Comparison of time away from work and sport will be compared at 12 months.

Statistical analysis will be completed using a validated statistical programme such as SPSS. Mean ATRS and HRQOL scores will be compared using two sided student t-tests at the various time points. Linear mixed effect regression analysis of ATRS and HRQOL scores will also be completed and adjusted for confounding factors such as gender and age. Results will be deemed significant if p values are smaller than 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/12/2018
Actual
Date of last participant enrolment
Anticipated
7/12/2020
Actual
Date of last data collection
Anticipated
13/12/2021
Actual
Sample size
Target
172
Accrual to date
Final
Recruitment outside Australia
Country [1] 21029 0
New Zealand
State/province [1] 21029 0
Wellington

Funding & Sponsors
Funding source category [1] 301171 0
Hospital
Name [1] 301171 0
Capital and Coast District Health Board
Country [1] 301171 0
New Zealand
Primary sponsor type
Individual
Name
Mr Giles Foley
Address
Orthopaedics Department
Wellington Hospital
Riddeford Street
Newtown
Wellington
6021
Country
New Zealand
Secondary sponsor category [1] 300795 0
None
Name [1] 300795 0
Address [1] 300795 0
Country [1] 300795 0
Other collaborator category [1] 280421 0
Individual
Name [1] 280421 0
Dr Henry Smart
Address [1] 280421 0
Wellington Hospital
Riddeford Street
Newtown
Wellington
6021
Country [1] 280421 0
New Zealand
Other collaborator category [2] 280422 0
Individual
Name [2] 280422 0
Dr Alice Rogan
Address [2] 280422 0
Wellington Hospital
Riddeford Street
Newtown
Wellington
6021
Country [2] 280422 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301915 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 301915 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 301915 0
New Zealand
Date submitted for ethics approval [1] 301915 0
09/11/2018
Approval date [1] 301915 0
Ethics approval number [1] 301915 0

Summary
Brief summary
Achilles tendon rupture is a common injury but to date there is no consensus with regards to the optimal conservative management strategy. For surgically managed Achilles tendon rupture guidelines support immediate weight bearing in functional orthotics due to the superior functional and clinical outcomes. We aim to compare the use of immediate weightbearing in functional orthotic braces versus standard non weight bearing management for non-operatively managed Achilles tendon rupture.

All patients presenting to Wellington Regional Hospital with Achilles tendon rupture will be screened for eligibility for the study. Included patients will be randomised to standard therapy in a non-weight bearing Equinus cast or a weight bearing VACOped orthotic brace. This study will recruit 86 patients to each study arm. ATRS scores, VR-12 quality of life scores and complication rates will be collected at 3, 6, and 12 months post injury. Results will be analysed on an intention to treat basis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88546 0
Mr Giles Foley
Address 88546 0
Wellington Orthopaedic Department, Wellington Regional Hospital, Riddiford Street, Wellington, 6021
Country 88546 0
New Zealand
Phone 88546 0
+64 4 385 5999
Fax 88546 0
Email 88546 0
[email protected]
Contact person for public queries
Name 88547 0
Giles Foley
Address 88547 0
Wellington Orthopaedic Department, Wellington Regional Hospital, Riddiford Street, Wellington, 6021
Country 88547 0
New Zealand
Phone 88547 0
+64 4 385 5999
Fax 88547 0
Email 88547 0
[email protected]
Contact person for scientific queries
Name 88548 0
Giles Foley
Address 88548 0
Wellington Orthopaedic Department, Wellington Regional Hospital, Riddiford Street, Wellington, 6021
Country 88548 0
New Zealand
Phone 88548 0
+64 4 385 5999
Fax 88548 0
Email 88548 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
234Study protocol    376372-(Uploaded-14-11-2018-08-21-29)-Study-related document.docx



Results publications and other study-related documents

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