Trial Review

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Trial registered on ANZCTR


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 1197 0
Condition category
Condition code
Injuries and Accidents 1282 1282 0 0
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] 1012 0
Diagnosis / Prognosis
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1732 0
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] 1732 0
Final outcomes of the study would be assessed at 6 weeks post injury.
Primary outcome [2] 1733 0
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] 1733 0
Final outcomes of the study would be assessed at 6 weeks post injury.
Primary outcome [3] 1734 0
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] 1734 0
Final outcomes of the study would be assessed at 6 weeks post injury.
Primary outcome [4] 1735 0
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] 1735 0
Assessed at the end of the study (1 year).
Secondary outcome [1] 3094 0
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] 3094 0

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
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Phase
Phase 2
Type of endpoint/s
Efficacy
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] 1404 0
Hospital
Name [1] 1404 0
Ballarat Health Services
Country [1] 1404 0
Australia
Funding source category [2] 1405 0
Government body
Name [2] 1405 0
National Institute of Clinical Studies
Country [2] 1405 0
Australia
Primary sponsor type
Hospital
Name
Ballarat Health Services (BHS)
Address
Country
Australia
Secondary sponsor category [1] 1234 0
Government body
Name [1] 1234 0
National Institute of Clinical Studies (NICS)
Address [1] 1234 0
Country [1] 1234 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2764 0
Ballarat Base Hospital
Ethics committee address [1] 2764 0
Ethics committee country [1] 2764 0
Australia
Date submitted for ethics approval [1] 2764 0
Approval date [1] 2764 0
09/03/2006
Ethics approval number [1] 2764 0
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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35956 0
Address 35956 0
Country 35956 0
Phone 35956 0
Fax 35956 0
Email 35956 0
Contact person for public queries
Name 10201 0
Jaycen Cruickshank
Address 10201 0
Emergency Department
Ballarat Base Hospital
Cnr Drummond and Mair Sts,
Ballarat VIC 3350
Country 10201 0
Australia
Phone 10201 0
+61 3 53204000
Fax 10201 0
Email 10201 0
jaycenc@bhs.org.au
Contact person for scientific queries
Name 1129 0
Merle Weber
Address 1129 0
Emergency Department
Ballarat Base Hospital
Cnr Drummond and Mair Sts
Ballarat VIC 3350
Country 1129 0
Australia
Phone 1129 0
+61 3 53204000
Fax 1129 0
Email 1129 0
merle4154@westnet.com.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

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Documents added automatically
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