ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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).

Condition category

Condition code

Injuries and Accidents

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]

Diagnosis / Prognosis

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Interobserver reliability of diagnosis of fractures of the wrist and carpals (kappa)

Timepoint [1]

Collated when all nine radiologists have reported, and analysed by statistician.

Secondary outcome [1]

Description of the actual diagnoses reached by the reporting radiologists when their reports are complete.

Timepoint [1]

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?

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]

University

Name [1]

Advanced Medical Science (University of Melbourne)

Address [1]

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Ballarat Health Services

Address [2]

Country [2]

Australia

Primary sponsor type

Individual

Name

Investigator (Ballarat Health Services)

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ballarat Health Services & St John of God HREC

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Jaycen Cruickshank

Address

Mair & Drummond St Ballarat 3350 Victoria
PO Box 577 Ballarat 3353 VIC

Country

Australia

Phone

+61 3 53206455

Fax

+61 3 53204758

[email protected]

Contact person for scientific queries

Name

Dr Jaycen Cruickshank

Address

Emergency Department
Mair & Drummond St Ballarat 3350 Victoria
PO Box 577 Ballarat 3353 Victoria

Country

Australia

Phone

+61 3 53206455

Fax

+61 3 53204758

[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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically