|
ISRCTN
|
ISRCTN04356218
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The Bristol Hip View For Evaluation of Fractured Neck of Femur
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0234175548
|
|
Study hypothesis
|
1. Will a modified plain radiograph view (X-ray) help in the diagnosis of fractures to the femoral neck to avoid missed fractures?
2. Does the proposed radiographic view statistically increase the visibility of fractured femoral necks when reviewed by orthopaedic surgeons and radiologists?
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Injury, Occupational Diseases, Poisoning: Factures
|
|
Participants - inclusion criteria
|
Patients who present with a history and examination compatible with a fracture of the upper femur.
|
|
Participants - exclusion criteria
|
Patients will be excluded if they are unable to understand the study details and hence unable to provide written consent. As the study involves a small additional dose of radiation anybody under 60 years old will be excluded
|
|
Anticipated start date
|
01/01/2006
|
|
Anticipated end date
|
31/12/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Proposed number of patients: 150
|
|
Interventions
|
Our aims are to see if the modified radiographic view, in addition to the standard series of 2 radiographs increases the pick up rate and visibility of femoral neck fractures.
The standard 2 radiographs that are already done will act as the control.
How subjects are approached:
Patients presenting to the emergency department with a history and examination findings consistent with a fractured upper femur will have the study explained by the examining doctor. The patients will be consented to have an additional radiograph as well as the standard series. The patient will be X-rayed as standard and then the additional radiograph will be performed.
All other treatment will be as standard.
|
|
Primary outcome measure(s)
|
The anonymised radiographs will be reviewed by anonymised observers, orthopaedic surgeons, A&E staff and radiologists. The anonymised radiographs will be randomised and any abnormality noted by anonymised observers via a questionnaire. The questionnaire will remain confidential and will not hold any patient identification or personal information. Any further information which is evident from the additional view is to be recorded. Note is made of the confidence of the initial diagnosis, and how the additional radiograph has helped. The proposal has been made after discussion with orthopaedic surgeons, A&E staff and the radiographer-lead to ensure the pathway is feasible and will not add significantly to the workload of the department.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
North Bristol NHS Trust (UK)
NHS R&D Support Funding
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
M
Bradley
|
|
Address
|
Southmead Hospital
Westbury on Trym
|
|
City/town
|
Bristol
|
|
Zip/Postcode
|
BS105NB
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 01179595524
|
|
Fax
|
+44
|
|
Email
|
mike.bradley@nbt.nhs.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
29/09/2006
|
|
Last edited
|
11/10/2011
|
|
Date ISRCTN assigned
|
29/09/2006
|
