Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000721202
Ethics application status
Approved
Date submitted
19/08/2009
Date registered
24/08/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is bedside ultrasound a valuable tool for diagnosing common fractures in emergency department patients?
Scientific title
Is bedside ultrasound a valuable tool for diagnosing common fractures in emergency department patients?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy patients with/without fractures. 243545 0
Condition category
Condition code
Musculoskeletal 239849 239849 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prospective convenience sampling of patients with suspected fracture of selected regions. Perform bedside ultrasonography using portable SONOSITE MicroMaxx ultrasound machine using a 12MHz transducer. Patients will be observed for 6 months.
Intervention code [1] 241152 0
Diagnosis / Prognosis
Comparator / control treatment
Comparing to diagnosis made from Xray/Computerised Tomography scan (CT)/Magnetic Resonance Imaging (MRI).
Control group
Active

Outcomes
Primary outcome [1] 240614 0
Sensitivity of using ultrasound to diagnose fractures.
Timepoint [1] 240614 0
At completion of ultrasound scan and/or Xray/CT/MRI whichever is later.
Primary outcome [2] 240615 0
Specificity of using ultrasound to diagnose fractures.
Timepoint [2] 240615 0
At completion of ultrasound scan and/or Xray/CT/MRI whichever is later.
Secondary outcome [1] 257252 0
To determine if time to correct diagnosis of the presence or absence of fracture can be reduced by the use of Ultrasound
Timepoint [1] 257252 0
At completion of ultrasound scan and/or Xray/CT/MRI whichever is later.

Eligibility
Key inclusion criteria
Patient with suspected fractures involving the metacarpal, distal radius/ulnar, olecranon, body of ulnar, clavicle, metatarsal, distal tibia/fibula, patella, proximal fibula, mandible or sternum.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient unable to give own consent
Patients with unstable, compound (open) or suspected open fractures
Haemodynamically unstable patients requiring urgent medical intervention
Patients with fracture dislocations requiring immediate relocation to avoid neurovascular compromisation
Enrolling clinician has already reviewed Xrays and made diagnosis prior performing ultrasound for the study

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237519 0
Self funded/Unfunded
Name [1] 237519 0
Country [1] 237519 0
Primary sponsor type
Individual
Name
Ngee Wei Foo
Address
Department of Emergency Medicine
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 236997 0
None
Name [1] 236997 0
Address [1] 236997 0
Country [1] 236997 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243651 0
Royal Adelaide Hospital Ethics Committee
Ethics committee address [1] 243651 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 243651 0
Australia
Date submitted for ethics approval [1] 243651 0
Approval date [1] 243651 0
02/07/2009
Ethics approval number [1] 243651 0
RAH Protocol No 090702

Summary
Brief summary
The primary purpose of this study is to determine if using a bedside ultrasound machine is as good as using an Xray to determine if a bone is fractured. A positive outcome from this study may speed up the treatment of patients with similar injuries and avoid unecessary exposure to radiation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30069 0
Address 30069 0
Country 30069 0
Phone 30069 0
Fax 30069 0
Email 30069 0
Contact person for public queries
Name 13316 0
Dr. Ngee Wei Foo
Address 13316 0
Department of Emergency Medicine
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 13316 0
Australia
Phone 13316 0
(+618) 82224000
Fax 13316 0
Email 13316 0
Ngee.Foo@health.sa.gov.au
Contact person for scientific queries
Name 4244 0
Dr. Ngee Wei Foo
Address 4244 0
Department of Emergency Medicine
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 4244 0
Australia
Phone 4244 0
(+618) 82224000
Fax 4244 0
Email 4244 0
Ngee.Foo@health.sa.gov.au

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.