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Trial registered on ANZCTR


Registration number
ACTRN12614001118695
Ethics application status
Not yet submitted
Date submitted
7/10/2014
Date registered
22/10/2014
Date last updated
22/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Performance Evaluation of Adjustable External Splint for Wrist Fracture (Distal Radius Fracture)
Scientific title
Evaluation of clinical effectiveness and practicality of adjustable external splint(Zero-Cast) for distal radius fracture against conventional plaster cast
Secondary ID [1] 285446 0
None
Universal Trial Number (UTN)
U1111-1162-6379
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extra-articular distal radius fracture 293213 0
Condition category
Condition code
Injuries and Accidents 293482 293482 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Duration of Use: until fracture has healed
Healthcare Professionals will be administering the splint and giving instructions on how to maintain the splint. Any adjustment of the splint position will be done by healthcare professional.

Name of the Splint: Zero-cast (Adjustable External Splint for Distal Radius Fracture)

Participants will be followed up by healthcare professional at week 1,2 and 6.
Intervention code [1] 290378 0
Treatment: Devices
Comparator / control treatment
Traditional plaster cast (Plaster of Paris and/or Scotchcast)
6 week or until the fracture healed
Control group
Active

Outcomes
Primary outcome [1] 293310 0
Maintenance of fracture reduction during the period of fracture healing. it will be measure using standard lateral X-ray of wrist.
Timepoint [1] 293310 0
Follow-Up at 1week, 2 week, and 6 week.
Secondary outcome [1] 310777 0
Patient-related outcome:Wrist function score
Timepoint [1] 310777 0
Follow-Up at 1week, 2 week, and 6 week.
Secondary outcome [2] 310852 0
Healthcare related outcome (Ease of use, Adjustability, Time of procedure)Measure using pre-designed Questionnaire
Timepoint [2] 310852 0
Follow-Up at 1week, 2 week, and 6 week.

Eligibility
Key inclusion criteria
Extraarticular Distal radius fracture less than 6cm from joint surface
Patient with distal radius fracture configuration who can be treated by below elbow plaster cast
Minimum age
4 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No patient under age of 4 or over 75
Patient unable to provide informed consent
Patient who cannot complete the study protocol
Patient who requires surgical intervention
Patient with previous deformity
Patient who does not belong to defined size range
Patient with skin disease and allergic reactions
Patient with open fractures.
Patient with multiple fractures
Patient with multiple injuries

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/11/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 6393 0
New Zealand
State/province [1] 6393 0

Funding & Sponsors
Funding source category [1] 290054 0
Government body
Name [1] 290054 0
Callaghan Innovation
Country [1] 290054 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Surgisplint Limited
Address
PO Box 305 543
Triton Plaza
Auckland 0757
Country
New Zealand
Secondary sponsor category [1] 288742 0
None
Name [1] 288742 0
Address [1] 288742 0
Country [1] 288742 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291760 0
Health and Disability Ethics Committees
Ethics committee address [1] 291760 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 291760 0
New Zealand
Date submitted for ethics approval [1] 291760 0
20/10/2014
Approval date [1] 291760 0
Ethics approval number [1] 291760 0

Summary
Brief summary
Distal radius fracture (wrist fracture) is a common an injury and accounts for approximately 1/3rd of wall wrist injuries. These type of fractures can managed in several ways and are determined by several factors. In fractures that have not displaced or are stable once they have been set they usually do not require an operation and are kept in position by the use of an external plaster. This current method of keeping the fracture well positioned often delivers acceptable results. However, plaster can be inconvenient to the patient. Patients find it cumbersome, they often report problems like, itching, difficult to maintain hygiene, inability to use the limb. It often needs regular changing of plaster during course of treatment. The adjustable external splint (Zero-Cast) was designed to have similar clinical functionality as traditional plaster cast, however aimed to reduce the problems reported by traditional plaster immobilization.
This research has been designed to assess whether the splint can maintain adequate fracture position and be more comfortable and manageable both for the patient and the Doctor/Technician managing the fracture.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51906 0
Dr Sarmad Iwaz
Address 51906 0
Tepuna Hauora clinic
58a Akoranga Dr,
Northcote, 0627
North Shore City
Country 51906 0
New Zealand
Phone 51906 0
6494769246
Fax 51906 0
Email 51906 0
[email protected]
Contact person for public queries
Name 51907 0
Danny Chun
Address 51907 0
Surgisplint Ltd
PO Box 305 543
Triton Plaza
Auckland 0757
Country 51907 0
New Zealand
Phone 51907 0
6494769246
Fax 51907 0
Email 51907 0
[email protected]
Contact person for scientific queries
Name 51908 0
Pranesh Kumar
Address 51908 0
Surgisplint Ltd
9E Apollo Drive
Rosedale
Auckland 0632
Country 51908 0
New Zealand
Phone 51908 0
6494769246
Fax 51908 0
Email 51908 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.