Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001085965
Ethics application status
Approved
Date submitted
4/10/2011
Date registered
19/10/2011
Date last updated
28/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of Ultrasound in Forearm Fractures versus Investigation with X-ray
Scientific title
Investigation in the paediatric (under 16) population looking at the use of a focused ultrasound training package to enable doctors to diagnose or exclude forearm fractures. The results will be compared with the current gold standard of X-ray looking at the sensitivity and specificity of ultrasound.
Secondary ID [1] 273166 0
none
Universal Trial Number (UTN)
U1111-1125-0236
Trial acronym
SUFFIX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Forearm injuries from trauma in children- looking for potential fractures. 278916 0
Condition category
Condition code
Injuries and Accidents 279095 279095 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound scan (USS) will be performend in the department by an emergency doctor that has undergone the on line training package designed for this trial. It will be a single USS and should take 10-15 minutes to complete.
Following routine examination and USS the patient will then go on to have an x-ray which is the current gold standard in fracture diagnosis. The ultrasound will always be performed prior to the xray (this is why children with prior imaging are excluded) to ensure that the doctor performing the scan is not biased. As it is not a drug intervention there is no "wash out" period and the xray request will be made directly after the scan is complete.
Intervention code [1] 269496 0
Diagnosis / Prognosis
Comparator / control treatment
xray will be performed in the departmental xray room by the hospital radiologists as is the current practice when investigating for fracture. Only one xray is normally requested unless views are inadequate in which case specialists may request further (this is out of the departments direct control). Xray takes a matter of minutes to perform.
Control group
Active

Outcomes
Primary outcome [1] 279732 0
The ability of ultrasound to safely exclude a fracture of the forearm.
This will be assessed by the doctor performing the scan filling in a data collection sheet reporting their findings and by capture of still annonomysed images for review by an ultrasound expert (for quality control purposes). The doctors assessment of wether there is a fracture will be compared to the gold standard xray that is routinely reported by a radiologist. The radiologist will not be aware of the ultrasound findings.
Timepoint [1] 279732 0
at baseline (once compared to gold standard x-ray report)
Primary outcome [2] 279733 0
The ability of ultrasound to accurately diagnose fractures and assess angulation
This will be assessed by the doctor performing the scan filling in a data collection sheet reporting their findings and by capture of still annonomysed images for review by an ultrasound expert (for quality control purposes). The doctors assessment of wether there is a fracture will be compared to the gold standard xray that is routinely reported by a radiologist. The radiologist will not be aware of the ultrasound findings.
Timepoint [2] 279733 0
at baseline
Secondary outcome [1] 294326 0
The accepatability of ultrasound as a diagnostic tool to parents and patients using visual analogue scales to compare any discomfort associated with examination, ultrasound and x-ray.
Timepoint [1] 294326 0
at baseline

Eligibility
Key inclusion criteria
a history of trauma to the forearm with a suspected fracture presenting to a childrens emergency department
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
evidence of an open fracture (ie broken skin)
previous imaging done elsewhere (ie diagnosis known)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
children are identified as eligable from triage and are consented and enrolled by medical staff examining them. All children will be examined, ultrasounded and xrayed so there is no randomisation. It is an interventional trial as we are assessing a different method of diagnosis of fractures but also doing an xray as this is the current gold satndard.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
all subjects will receive both an ultrasound and xray
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269977 0
Self funded/Unfunded
Name [1] 269977 0
Country [1] 269977 0
Primary sponsor type
Individual
Name
Prof. G Geelhoed
Address
c/o Princess Margaret Hospital Emergency Department
Roberts Road
Subiaco
WA 6008
Country
Australia
Secondary sponsor category [1] 268969 0
Individual
Name [1] 268969 0
Dr James Rippey
Address [1] 268969 0
c/o Emergency Department
Sir Charles Gardiner Hospital
Perth WA 6008
Country [1] 268969 0
Australia
Other collaborator category [1] 252280 0
Individual
Name [1] 252280 0
Dr Rachel Rowlands
Address [1] 252280 0
c/o Princess Margaret Hospital Emergency Department
Roberts Road
Subiaco
WA 6008
Country [1] 252280 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271940 0
Princess Margaret Hospital for Children Ethics Commitee
Ethics committee address [1] 271940 0
Ethics committee country [1] 271940 0
Australia
Date submitted for ethics approval [1] 271940 0
Approval date [1] 271940 0
01/09/2011
Ethics approval number [1] 271940 0
1934/EP

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

Contacts
Principal investigator
Name 33235 0
Address 33235 0
Country 33235 0
Phone 33235 0
Fax 33235 0
Email 33235 0
Contact person for public queries
Name 16482 0
Dr Rachel Rowlands
Address 16482 0
c/o Princess Margaret Hospital
Robert Road
Subiaco, WA 6008
Country 16482 0
Australia
Phone 16482 0
+61 8 93408272
Fax 16482 0
Email 16482 0
[email protected]
Contact person for scientific queries
Name 7410 0
Prof. Gary Geelhoed
Address 7410 0
c/o Princess Margaret Hospital
Robert Road
Subiaco, WA 6008
Country 7410 0
Australia
Phone 7410 0
+61 8 93408272
Fax 7410 0
Email 7410 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.