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Trial registered on ANZCTR


Registration number
ACTRN12617001606370p
Ethics application status
Not yet submitted
Date submitted
6/11/2017
Date registered
7/12/2017
Date last updated
7/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Wrist splint versus conventional casting for the management of wrist fractures.
Scientific title
A prospective randomised control trial evaluating the clincial efficacy and patient satisfaction scores of a novel adjustable wrist splint (Zero-Cast) for the treatment of distal wrist fractures.
Secondary ID [1] 293289 0
N/A
Universal Trial Number (UTN)
U1111-1204-7085
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal wrist fractures 305363 0
Condition category
Condition code
Injuries and Accidents 304651 304651 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a RCT with two arms - intervention group and control. The intervention group will have their distal radius fracture managed with the adaptable wrist splint (low risk medical device) to immobilise the fracture. This will be applied by the fracture clinic staff who are qualified nurses and doctors. Their management of clinic attendance will follow the same protocol as the control group (traditional plaster cast) in terms of follow up appointment and X-rays. The researcher (registered physiotherapist) will moniter both groups weekly with telephone questionnaires and identify any risks as appropriate to refer onto the orthodpaedic consultant. The adaptable wrist splint is a custom fitted, prefabricated ride device which allows for adjustment and adaptation for fracture reduction and stabilisation. It consists of a volar plate, dorsal plate, proximal strap and ratchet-legs linking the volar and dorsal plates together. Once the plates are pressed together guided by the ratchet legs , it is then locked. The device is not able to be removed by participants at any time. The overall duration of splint wear is for 6 weeks.
Intervention code [1] 299542 0
Treatment: Devices
Comparator / control treatment
The control group will be managed with traditional plaster cast to immobilise the fractures.
Control group
Active

Outcomes
Primary outcome [1] 303872 0
The modified Patient Reported Wrist Evaluation looks at pain and function. This is a. composite outcome. The pain rating is the average amount of pain in the wrist over the past week. The scale is from zero (never) to 10 (always). It specifically asks for ratings at rest; when doing a task with a repeated wrist movement when lifting a heavy object; when it is at its worst and how often you have pain. The function looks at specific activities where you rate the amount of difficulty you experience over the past week performing on a scale of; zero (no difficulty) to 10 (it was so difficult you were unable to do it). The specific activities are turn a door knob using my affected hand; cut meat using a knife in my affected hand; fasten buttons on my shirt; use my affected hand to push up fro a chair;carry a 4.5 kg object in my affected hand and use bathroom tissue with my affected hand. The usual activities rate again from zero (you did not experience any difficulty) to 10 (it was so difficult you were unable to do it) included; personal care activities (washing, dressing); household work (cleaning, maintenance); when lifting a heavy object; work (your job or usual everyday work) and recreational activities).
Timepoint [1] 303872 0
The modified Patient Reported Wrist Evaluation is completed at the beginning of the trial and each week until the end of the trial at week 6. Week 6 will be considered to be the primary endpoint.
Secondary outcome [1] 340430 0
Maintenance of fracture position
Timepoint [1] 340430 0
Xrays will be taken once the adaptable wrist splint is initially applied in fracture clinic. The next x-ray taken will be at 6 weeks. This is in line with the current protocol for management of distal radius wrist fractures treated with plaster cast. Xray one - 7 to 10 days post fracture once adaptable wrist splint is applied.
Xray two - 6 weeks post fracture.
Secondary outcome [2] 340432 0
Health care users perception of comfort and convenience of adaptable wrist splint.
Timepoint [2] 340432 0
This will be completed at week 1 of using the adaptable wrist splint. The questionnaire is called " initial healthcare user questionnaire". It rates on a scale of 1 (comfortable ) to 10 (uncomfortable). The two questions are to rate comfort and convenience.
Secondary outcome [3] 340446 0
Health professionals experience of using adaptable wrist splint
Timepoint [3] 340446 0
The questionnaire "Doctor/Nurse Practitioner/ Plaster Technician Questionnaire" will be used after health user participant contact at fracture clinic at week 1 and week 6. This questionnaire will evaluate the ease of application and ease of alterations on a scale of 1 (easy) to 10 (hard). It will also rate how well the adaptable wrist splint was tolerated on a scale of 1 (poor) to 10 (excellent )

Eligibility
Key inclusion criteria
Non-displaced distal radius fracture.
Able to give informed consent.
Age 65 and over.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Displaced distal radius fractures that require manipulation or surgery.
Unable to give informed consent.
Under the age of 65 years old.

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 not be blinded to randomisation allocation. There will be blinded assessments at baselines, weeks 1-6 and final assessments. To determine PRWE and pain levels, there will be blinded assessment of fracture healing on xray.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was ascertained by a randomisation schedule held at a distant site (25 in the intervention group and 25 in the control). This schedule was compiled by an independent researcher. Allocation occurred by telephone to a central randomisation service provided.
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
Efficacy
Statistical methods / analysis
To detect a 25% reduction in PRWSE scores with a mean value of 44 and a SD of 11(1) we estimate we need 21 patients in each group (42 total), two tailed test (a=0.05, power= 90%).

Outcome measures will be analysed using generalised linear regression which will allow for the correlations between data measured on the same person. These will be used to investigate the changes over time in the secondary endpoints and whether these changes differ between the control and intervention groups. The appropriate link function will be used depending on whether the outcome is continuous, categorical or ordinal. Important baseline characteristics will be included in the models.
The one-on-one interviews will be analysed using a general inductive approach as this is a common systematic procedure used for analysing qualitative data.
(1) Walenkamp, M. M., et al. (2015). "The minimum clinically important difference of the patient-rated wrist evaluation score for patients with distal radius fractures." Clinical Orthopaedics and Related Research 473(10): 3235-3241.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2018
Actual
Date of last participant enrolment
Anticipated
1/07/2018
Actual
Date of last data collection
Anticipated
12/08/2018
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment outside Australia
Country [1] 9334 0
New Zealand
State/province [1] 9334 0
Waikato

Funding & Sponsors
Funding source category [1] 297913 0
Commercial sector/Industry
Name [1] 297913 0
Surgionix
Country [1] 297913 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato District Health Board
Address
Department of Allied Health, Rehabilitation and Older Persons
Waikato Hospital
Pembroke Street
Hamilton
3204
Country
New Zealand
Secondary sponsor category [1] 296973 0
None
Name [1] 296973 0
Address [1] 296973 0
Country [1] 296973 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298963 0
Health and Disability Ethics Committee
Ethics committee address [1] 298963 0
Ethics committee country [1] 298963 0
New Zealand
Date submitted for ethics approval [1] 298963 0
04/12/2017
Approval date [1] 298963 0
Ethics approval number [1] 298963 0

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

Contacts
Principal investigator
Name 78810 0
Miss Victoria Donoghue
Address 78810 0
Bupa Research Associate
Department of Allied Health, Rehabilitation and Older Adults,
Waikato Hospital
Pembroke Street
Hamilton
3204
Country 78810 0
New Zealand
Phone 78810 0
+64 27 416 3055
Fax 78810 0
Email 78810 0
[email protected]
Contact person for public queries
Name 78811 0
Victoria Donoghue
Address 78811 0
Department of Allied Health, Rehabilitation and Older Adults
Waikato Hospital
Pembroke Street
Hamilton
3204
Country 78811 0
New Zealand
Phone 78811 0
+64 27 416 3055
Fax 78811 0
Email 78811 0
[email protected]
Contact person for scientific queries
Name 78812 0
John Parsons
Address 78812 0
University of Auckland
85 Park Road
Grafton
Auckland
1142
Country 78812 0
New Zealand
Phone 78812 0
+64 21 532980
Fax 78812 0
Email 78812 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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