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
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
Prof Matthew Costa
John Radcliffe Hospital
+44 1865 223111
World Hip Trauma Evaluation: a comprehensive cohort study of patients with fracture of the
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.
National Research Ethics Committee, London - Camberwell St Giles, 18/08/2011, ref: 11/LO/0927
Comprehensive cohort study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please contact firstname.lastname@example.org to request a patient information sheet
Proximal femur fracture
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
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
Overall trial end date
Reason abandoned (if study stopped)
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
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
Recruitment end date
Countries of recruitment
Trial participating centre
Kadoorie Centre John Radcliffe Hospital
University of Oxford
c/o Ms Heather House
Head of Clinical Trials Research Governance Team
+44 1865 572224
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)