ISRCTN ISRCTN04356218
DOI https://doi.org/10.1186/ISRCTN04356218
Protocol serial number N0234175548
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders North Bristol NHS Trust (UK), NHS R&D Support Funding (UK)
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
01/10/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M Bradley
Scientific

Southmead Hospital
Westbury on Trym
Bristol
BS105NB
United Kingdom

Phone +44 01179595524
Email mike.bradley@nbt.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedInjury, Occupational Diseases, Poisoning: Factures
InterventionOur 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 typeOther
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.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target sample size at registration150
Key inclusion criteriaPatients who present with a history and examination compatible with a fracture of the upper femur
Key exclusion criteriaPatients 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
Date of first enrolment01/01/2006
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Southmead Hospital
Bristol
BS105NB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2013 Yes No