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Trial registered on ANZCTR


Registration number
ACTRN12607000342415
Ethics application status
Not yet submitted
Date submitted
24/06/2007
Date registered
26/06/2007
Date last updated
26/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Inter-observer reliability of radiologist reports in scaphoid and carpal Computed Tomography (CT).
Scientific title
Inter-observer reliability of radiologist interpretation of Computed Tomography (CT) in patients with clinical scaphoid fracture and normal x-rays
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with clinical scaphoid fracture and normal x-rays, who had Computed Tomography (CT). 1893 0
Condition category
Condition code
Injuries and Accidents 1988 1988 0 0
Fractures

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Computed Tomography (CT) carpals. These images already available, collected over three years, now radiologists (9) will provide reports (blinded) in one session on a sample of 15 Computed Tomography (CT), recruiting radiologists over three months or until nine recruited.
Intervention code [1] 1847 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 2809 0
Interobserver reliability of diagnosis of fractures of the wrist and carpals (kappa)
Timepoint [1] 2809 0
Collated when all nine radiologists have reported, and analysed by statistician.
Secondary outcome [1] 4735 0
Description of the actual diagnoses reached by the reporting radiologists when their reports are complete.
Timepoint [1] 4735 0

Eligibility
Key inclusion criteria
Inclusion criteria for reporting radiologists (n=9)Fellowship of the college of radiologistsCurrently practisingVoluntary participationCompleted the written informed consent form. Inclusion criteria for patients Mechanism of injury consistent with scaphoid trauma, tenderness on the anatomical snuff box, and normal initial x-rays.
Minimum age
24 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for reporting radiologists: Declined to participate Exclusion criteria for patients: Unable to provide informed consentRefused consentPregnantAge <14 years

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
135
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2128 0
University
Name [1] 2128 0
Advanced Medical Science (University of Melbourne)
Country [1] 2128 0
Australia
Funding source category [2] 2129 0
Hospital
Name [2] 2129 0
Ballarat Health Services
Country [2] 2129 0
Australia
Primary sponsor type
Individual
Name
Investigator (Ballarat Health Services)
Address
Country
Australia
Secondary sponsor category [1] 1935 0
None
Name [1] 1935 0
nil
Address [1] 1935 0
Country [1] 1935 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3924 0
Ballarat Health Services & St John of God HREC
Ethics committee address [1] 3924 0
Ethics committee country [1] 3924 0
Australia
Date submitted for ethics approval [1] 3924 0
Approval date [1] 3924 0
Ethics approval number [1] 3924 0

Summary
Brief summary
This project is related to our local research projects
1.Does early Computerised Tomography exclude fracture in ‘clinical scaphoid fracture’? (complete)
2.Introducing CT scans into a clinical pathway to manage “clinical fractured scaphoid”, using meditutes and patient specific reminders to implement the evidence. (in progress)
The scaphoid is one of the wrist bones. A fall on the outstretched hand is the usual mechanism of injury, and there is usually tenderness in a site known as the “anatomical snuff box”. Diagnosis of scaphoid fracture is difficult.
Patients expect that we will use the newest technology available to ensure accurate diagnosis and appropriate management. Bone scans have been used, but they cannot be used too early, so the patient will need a plaster anyway. Magnetic Resonance Imagin (MRI) is probably the international gold standard, but it is expensive and difficult to access in Australia
CT scans are relatively cheap and accessible in Australia. The technology is improving rapidly, and this study should help us answer the question: “Does early CT exclude fracture in ‘clinical scaphoid fracture’?”
In addition to establishing whether the result obtained from CT is positive or negative, we need to ask whether the CT is precise. Precision, or reproducibility, implies that results are nearly identical when repeated under the same conditions. Reproducibility is sometimes called reliability because when it is present, we can rely on the result from having one person report the test result. This study is designed to determine if we can rely on this test.
This study will test the reproducibility of CT reports using (n=9*15=135)
a sample of 9 specialist radiologists working in our region reporting on
a representative sample of 15 CTs from participants** in our first two studies.
** These participants have already consented to participating in research to determine the role of CT in this clinical situation. This study is related but needed to be conducted separately, as radiologists are now participants.
It is possible that our local research projects will contribute to CT becoming the gold standard for this clinical problem. It will at least contribute to a comparison of the evidence for CT and MRI, because for the “gold standard MRI” there is little published evidence regarding its precision and reliability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27661 0
Address 27661 0
Country 27661 0
Phone 27661 0
Fax 27661 0
Email 27661 0
Contact person for public queries
Name 11036 0
Dr Jaycen Cruickshank
Address 11036 0
Mair & Drummond St Ballarat 3350 Victoria
PO Box 577 Ballarat 3353 VIC
Country 11036 0
Australia
Phone 11036 0
+61 3 53206455
Fax 11036 0
+61 3 53204758
Email 11036 0
[email protected]
Contact person for scientific queries
Name 1964 0
Dr Jaycen Cruickshank
Address 1964 0
Emergency Department
Mair & Drummond St Ballarat 3350 Victoria
PO Box 577 Ballarat 3353 Victoria
Country 1964 0
Australia
Phone 1964 0
+61 3 53206455
Fax 1964 0
+61 3 53204758
Email 1964 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

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