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 20/09/2018: December 2011 to July 2020
Previous 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
Contact information
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
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 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
30/03/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participant inclusion criteria as of 21/09/2018:
Patients presenting with a fracture of the proximal femur to one of the participating sites
Previous 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
Sample size calculations will be undertaken for each of the embedded randomized controlled trials (RCTs), in the conventional manner. Details of sample size calculations for these embedded RCTs will be described in the relevant separate protocol for that research project.
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
03/07/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford Trauma
Kadoorie Centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
Sponsor information
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
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
Planned publication in a high-impact peer-reviewed journal.
Intention to publish date
30/03/2022
Participant level data
To be made available at a later date
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