ISRCTN ISRCTN63982700
DOI https://doi.org/10.1186/ISRCTN63982700
Submission date
13/12/2011
Registration date
20/03/2012
Last edited
26/02/2021
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

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 Orthopaedics 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?
January 2011 to March 2023

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

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

Study website

Contact information

Prof Matthew Costa
Scientific

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

Phone +44 1865 223111
Email white@ndorms.ox.ac.uk

Study information

Study designComprehensive cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please contact white@ndorms.ox.ac.uk to request a patient information sheet
Scientific titleWorld Hip Trauma Evaluation: a comprehensive cohort study of patients with fracture of the proximal femur
Study acronymWHiTE
Study objectivesNHS 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(s)National Research Ethics Committee, London - Camberwell St Giles, 18/08/2011, ref: 11/LO/0927
Health condition(s) or problem(s) studiedProximal femur fracture
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measureCurrent 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 measuresCurrent 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 study start date01/01/2011
Completion date01/03/2023

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsSample 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.
Key inclusion criteriaParticipant 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
Key exclusion criteria1. Patients younger than 60 years of age
2. Patients who are managed non-operatively
Date of first enrolment14/01/2012
Date of final enrolment31/08/2022

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

University of Oxford
University/education

c/o Ms Heather House
Head of Clinical Trials Research Governance Team
Oxford
OX1 3BD
England
United Kingdom

Phone +44 1865 572224
Email ctrg@admin.ox.ac.uk
Website https://www.ndorms.ox.ac.uk/research-groups/oxford-trauma
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date01/06/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/11/2012 Yes No
Results article results 21/10/2016 Yes No
Protocol article protocol for embedded pragmatic study 01/02/2021 26/02/2021 Yes No

Editorial Notes

26/02/2021: Publication reference added.
10/09/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 03/07/2020 to 31/08/2022.
2. The overall trial end date was changed from 30/03/2021 to 01/03/2023.
3. The intention to publish date was changed from 30/03/2022 to 01/06/2022.
4. Recruitment to this study is no longer paused.
27/04/2020: Due to current public health guidance, recruitment for this study has been paused.
21/09/2018: The following changes were made to the record:
1. The participant inclusion criteria was updated.
2. The target number of participants was added
3. The total target enrolment was added
20/09/2018: the plain English summary was updated
17/09/2018: The publication and dissemination plan and participant level data were updated.
14/09/2018: The recruitment end date was updated from 31/07/2018 to 03/07/2020 and the overall trial end date was updated from 28/02/2019 to 30/03/2021.
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".