The Bristol hip view for evaluation of fractured neck of femur
| ISRCTN | ISRCTN04356218 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04356218 |
| Secondary identifying numbers | N0234175548 |
- 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
Scientific
Southmead Hospital
Westbury on Trym
Bristol
BS105NB
United Kingdom
| Phone | +44 01179595524 |
|---|---|
| mike.bradley@nbt.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2006 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Proposed number of patients: 150 |
| Key inclusion criteria | Patients who present with a history and examination compatible with a fracture of the upper femur |
| Key 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 |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southmead Hospital
Bristol
BS105NB
United Kingdom
BS105NB
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
North Bristol NHS Trust (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
