Condition category
Injury, Occupational Diseases, Poisoning
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
01/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M Bradley

ORCID ID

Contact details

Southmead Hospital
Westbury on Trym
Bristol
BS105NB
United Kingdom
+44 01179595524
mike.bradley@nbt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0234175548

Study information

Scientific title

Acronym

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?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Injury, Occupational Diseases, Poisoning: Factures

Intervention

Our aims are to see if the modified radiographic view, in addition to the standard series of two radiographs, increases the pick-up rate and visibility of femoral neck fractures.

The standard two 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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

Not provided at time of registration

Overall trial start date

01/01/2006

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who present with a history and examination compatible with a fracture of the upper femur

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Proposed number of patients: 150

Participant 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

Recruitment start date

01/01/2006

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southmead Hospital
Bristol
BS105NB
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

North Bristol NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23365546

Publication citations

  1. Results

    Harding J, Chesser TJ, Bradley M, The Bristol hip view: its role in the diagnosis and surgical planning and occult fracture diagnosis for proximal femoral fractures., ScientificWorldJournal, 2013, 2013, 703783, doi: 10.1155/2013/703783.

Additional files

Editorial Notes