ANZCTR - Registration

Registration number

ACTRN12606000219583

Ethics application status

Approved

Date submitted

1/05/2006

Date registered

1/06/2006

Date last updated

1/06/2006

Type of registration

Retrospectively registered

Titles & IDs

Public title

Introducing CT scans into a clinical pathway to manage “clinical fractured scaphoid”

Scientific title

Implementing early CT scans to diagnose clinical fractured scaphoid and to avoid 10 days immobilization in plaster

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Clinical Scaphoid fracture. Ie, 'anatomical snuffbox' tenderness with normal plain x-rays

Condition category

Condition code

Injuries and Accidents

Fractures

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients in the study will receive an early CT instead of the usual 10 days in plaster. Patients will be treated based on the results of the CT scan.
If the CT shows a fracture, the patient would be treated for 6 weeks in plaster for a scaphoid fracture and 4 weeks in plaster for other carpal fractures. All patients with proven fractures will be reviewed by the orthopaedic registrar in the Fracture Clinic.
Patients with no evidence of fracture on CT would be treated as a soft tissue injury and discharged home. These patients would be followed up via a phone call 10-14 days post injury. Those with ongoing pain or disability would be asked to present for review by the Emergency Consultant with in the next 48 hours for clinical examination and repeat CT or MRI if indicated.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No comparator.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

All patients with proven fractures will be reviewed by the orthopaedic registrar in the Fracture Clinic at the next available appointment (usually 10-14 days after injury).
Patients with no evidence of fracture on CT would be treated as a soft tissue injury and discharged home. These patients would be followed up via a phone call 10-14 days post injury toassess ongoing pain and disability as well as patient satisfaction. Those with ongoing pain or disability would be asked to present for review by the Emergency Consultant with in the next 48 hours for clinical examination and repeat CT or MRI if indicated.

Final outcomes of the study includes return to work.

Timepoint [1]

Final outcomes of the study would be assessed at 6 weeks post injury.

Primary outcome [2]

All patients with proven fractures will be reviewed by the orthopaedic registrar in the Fracture Clinic at the next available appointment (usually 10-14 days after injury).
Patients with no evidence of fracture on CT would be treated as a soft tissue injury and discharged home. These patients would be followed up via a phone call 10-14 days post injury toassess ongoing pain and disability as well as patient satisfaction. Those with ongoing pain or disability would be asked to present for review by the Emergency Consultant with in the next 48 hours for clinical examination and repeat CT or MRI if indicated.

Final outcomes of the study includes missed fractures.

Timepoint [2]

Final outcomes of the study would be assessed at 6 weeks post injury.

Primary outcome [3]

All patients with proven fractures will be reviewed by the orthopaedic registrar in the Fracture Clinic at the next available appointment (usually 10-14 days after injury).
Patients with no evidence of fracture on CT would be treated as a soft tissue injury and discharged home. These patients would be followed up via a phone call 10-14 days post injury toassess ongoing pain and disability as well as patient satisfaction. Those with ongoing pain or disability would be asked to present for review by the Emergency Consultant with in the next 48 hours for clinical examination and repeat CT or MRI if indicated.

Final outcomes of the study includes patient satisfaction.

Timepoint [3]

Final outcomes of the study would be assessed at 6 weeks post injury.

Primary outcome [4]

All patients with proven fractures will be reviewed by the orthopaedic registrar in the Fracture Clinic at the next available appointment (usually 10-14 days after injury).
Patients with no evidence of fracture on CT would be treated as a soft tissue injury and discharged home. These patients would be followed up via a phone call 10-14 days post injury toassess ongoing pain and disability as well as patient satisfaction. Those with ongoing pain or disability would be asked to present for review by the Emergency Consultant with in the next 48 hours for clinical examination and repeat CT or MRI if indicated.

Final outcomes of the study includes the rate of missed fractures.

Timepoint [4]

Assessed at the end of the study (1 year).

Secondary outcome [1]

Using meditutes and patient specific reminders to implement the protocol.
A sample of Emergency Department (ED) notes (ie 6 months) continuous before and after intervention will be analysed to look for changes (ie documentation of snuffbox tenderness, anterior-posterior compression tenderness, and thumb axial compression tenderness, xray and CT results and follwoup arranged).

Timepoint [1]

Eligibility

Key inclusion criteria

A clinical scaphoid fracture will be defined as the presence of “snuffbox tenderness” in a patient with a mechanism of injury consistent with scaphoid trauma but normal initial radiographs. ED patients, who meet the clinical definition and had normal scaphoid x-rays.

Minimum age

14 Years

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Patients who are known to be pregnantPatients who are unable to give informed consentPatients who do not consent to participate.

Study design

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

3/04/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Ballarat Health Services

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Institute of Clinical Studies

Country [2]

Australia

Primary sponsor type

Hospital

Name

Ballarat Health Services (BHS)

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

National Institute of Clinical Studies (NICS)

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ballarat Base Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/03/2006

Ethics approval number [1]

06/MAR/2.1.1

Summary

Brief summary

With a clinically suspected scaphoid fracture, initial x-rays are unreliable. Current local practice is immobilization in plaster for 10 days with repeat x-rays, in order to not miss fractures.  In retrospect, up to 90% of patients do not need the plaster.
Advanced imaging (early MRI and Day 4 Bone scans) are proven as an alternate best practice, but are expensive and difficult to access, and thus not often used.
A research project at BHS has demonstrated that early CT scans are a reliable, accessible, cost effective alternative.
Our aim is to confirm the use of early CT and to implement early CT scans into a “best practice” clinical pathway for suspected scaphoid fractures.

Trial website

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Email

Contact person for public queries

Name

Jaycen Cruickshank

Address

Emergency Department
Ballarat Base Hospital
Cnr Drummond and Mair Sts,
Ballarat VIC 3350

Country

Australia

Phone

+61 3 53204000

Email

[email protected]

Contact person for scientific queries

Name

Merle Weber

Address

Emergency Department
Ballarat Base Hospital
Cnr Drummond and Mair Sts
Ballarat VIC 3350

Country

Australia

Phone

+61 3 53204000

Email

[email protected]

Trial Review

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Documents added automatically