Condition category
Injury, Occupational Diseases, Poisoning
Date applied
13/12/2011
Date assigned
20/03/2012
Last edited
01/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to evaluate the use of PROMs in the context of the National Hip Fracture Audit. It will record how well patients recover from their broken hip. The patients will be asked about their health using questionnaires in the post or over the telephone at 1 month, 4 months and 1 year.

Who can participate?
Patients presenting with a fracture of the proximal femur to University Hospital Coventry & Warwickshire NHS Trust.

What does the study involve?
The study involves using patient reported questionnaires to monitor activity level, general health and how well they are able to perform certain day-to-day tasks at 1 month, 4 months and 1 year following a hip fracture.

What are the possible benefits and risks of participating?
There are no specific benefits. There are no specific risks either. We will ask you to fill in some questionnaires. The information we get from this study may help us to treat future patients with hip fracture.

Where is the study run from?
The study is run from University Hospitals Coventry & Warwickshire NHS Trust & University
of Warwick.

When is the study starting and how long is it expected to run for?
Dec 2011 until Dec 2016

Who is funding the study?
NIHR Programme Development Grants (UK)

Who is the main contact?
Professor Matthew Costa
matthew.costa@warwick.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Matthew Costa

ORCID ID

Contact details

Trauma and Orthopaedic Surgery
Warwick Clinical Trials Unit
Division of Health Science
Warwick Medical School
University of Warwick
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom
+44 (0)2476 968 618
matthew.costa@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

-

Study information

Scientific title

World Hip Trauma Evaluation: a comprehensive cohort study of patients with fracture of the
proximal femur

Acronym

WHiTE

Study hypothesis

NHS Trusts are required to follow-up and record data about all patients admitted with a fracture of the proximal femur as part of the National Hip Fracture Audit. This Audit records data relevant to service evaluation but does not contain patient-centred outcomes (PROMs). Therefore, it cannot provide meaningful data regarding the clinical effectiveness of treatments.

The aim of this study is to evaluate the use of PROMs in the context of the National Hip Fracture Audit.

Ethics approval

National Research Ethics Committee, London - Camberwell St Giles, 18/08/2011, ref: 11/LO/0927

Study design

Comprehensive cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please contact Katie.mcguinness@warwick.ac.uk to request a patient information sheet

Condition

Proximal femur fracture

Intervention

Patients will receive normal standard of care operative treatments for their proximal femur fracture. The type of operation will depend on their fracture classification.
1. Undisplaced intracapsular - internal fixation
2. Displaced intracapsular -cemented hemiarthroplasty
3. Extracapsular and subtrochanteric - internal fixation

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

EQ-5D measured at 1 month, 4 months and 1 year

Secondary outcome measures

1. ICEpop CAPability measure for Older people [ICECAP(O)] at 1 month, 4 months and 1 year
2. Oxford Hip Score at 1 month, 4 months and 1 year
3. Re-operation and cause
4. Length of index hospital stay

Overall trial start date

01/12/2011

Overall trial end date

01/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Patients presenting with a fracture of the proximal femur to University Hospital Coventry & Warwickshire NHS Trust

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

N/A

Participant exclusion criteria

1. Patients younger than 60 years of age
2. Patients who are managed non-operatively

Recruitment start date

01/12/2011

Recruitment end date

01/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Warwick
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University Hospital Coventry & Warwickshire

Sponsor details

c/o Ms Ceri Jones
Research Manager
1st Floor
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 (0)2476 966196
ceri.jones@uhcw.nhs.uk

Sponsor type

Government

Website

http://www.uhcw.nhs.uk/

Organisation

University of Warwick

Sponsor details

c/o Dr Peter Hedges (Director of Research Support Services)
Coventry
CV4 7AL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

2012 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/23610662
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27797994

Publication citations

Additional files

Editorial Notes

01/11/2016: Publication reference added. 26/01/2016: The public and scientific titles have now been updated from the "Warwick Hip Trauma Evaluation" to the "World Hip Trauma Evaluation".