World Hip Trauma Evaluation

Plain English Summary

Background and study aims
Current as of 29/06/2017: This is cohort multiple embedded randomised controlled trial study. The study aims to capture data from the cohort of patients who present with a hip fracture at 21 NHS Trusts within the United Kingdom. We will record patient-reported outcomes and provide a baseline cohort within which to test the clinical effectiveness of experimental interventions through embedded randomised controlled trials.

Previous: 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?
Current as of 29/06/2017: Patients presenting to one of the NHS Trusts with a fracture of the proximal femur.
Previous: Patients presenting with a fracture of the proximal femur to University Hospital Coventry & Warwickshire NHS Trust.

What does the study involve?
Current as of 29/06/2017: 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 4 months following a hip fracture.

Previous: 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?
Current as of 29/06/2017: The study is sponsored by the University of Oxford and is run from Oxford Trauma, a part of the Nuffield Department of Othopaedics Rheumatology and Musculoskeletal Sciences.
Previous: 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?
Current as of 29/06/2017: December 2011 to August 2018
Previous: Dec 2011 until Dec 2016

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

Who is the main contact?
Professor Matthew Costa
white@ndorms.ox.ac.ik

Trial website

https://www.ndorms.ox.ac.uk/research-groups/oxford-trauma

Type

Scientific

Primary contact

Prof Matthew Costa

ORCID ID

Contact details

Oxford Trauma
Kadoorie Centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
+44 1865 223111
white@ndorms.ox.ac.uk

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

-

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 white@ndorms.ox.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 measure

Current outcome measures as of 29/06/2017:
EQ-5D measured at 120 days

Previous outcome measures:
EQ-5D measured at 1 month, 4 months and 1 year

Secondary outcome measures

Current secondary outcome measures as of 29/06/2017:
1. Mortality at 120 days
2. Complications at Baseline and 120 days
3. Residential Status at Baseline and 120 days
4. Mobility Status at Baseline and 120 days
5. Hospital information (Admission, assessment, treatment, discharge)
6. Resource Use at Baseline and 120 days

Previous 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

01/01/2011

Overall trial end date

28/02/2019

Reason abandoned (if study stopped)

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

14/01/2012

Recruitment end date

31/07/2018

Countries of recruitment

United Kingdom

Trial participating centre

Oxford Trauma
Kadoorie Centre John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Organisation

University of Oxford

Sponsor details

c/o Ms Heather House
Head of Clinical Trials Research Governance Team
Oxford
OX1 3BD
United Kingdom
+44 1865 572224
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

https://www.ndorms.ox.ac.uk/research-groups/oxford-trauma

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

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

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

Publication citations

29/06/2017: Added trial website. Updated contact information for patient information sheet. Updated Plain English summary to reflect over changes. Overall trial end dates changed from 01/12/2011- 01/12/2016 to 01/01/2011 - 28/02/2019. Recruitment dates changed from 01/12/2011 - 01/12/2016 to 14/01/2012 - 31/07/2018. The trial participating centre has changed from the University of Warwick to the University of Oxford. The sponsor has changed from the University Hospital Coventry and Warwickshire and the University of Warwick to Oxford University. Professor Costa (the study contact) institutional address has changed from the University of Warwick to John Radcliffe Hospital (UK). Outcome measures have been updated. 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".