World Hip Trauma Evaluation
| 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
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
Contact information
Scientific
Oxford Trauma
Kadoorie Centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
| Phone | +44 1865 223111 |
|---|---|
| white@ndorms.ox.ac.uk |
Study information
| Study design | Comprehensive cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please contact white@ndorms.ox.ac.uk to request a patient information sheet |
| Scientific title | World Hip Trauma Evaluation: a comprehensive cohort study of patients with fracture of the proximal femur |
| Study acronym | WHiTE |
| Study objectives | 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(s) | National Research Ethics Committee, London - Camberwell St Giles, 18/08/2011, ref: 11/LO/0927 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2011 |
| Completion date | 01/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | 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. |
| Key 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 |
| Key exclusion criteria | 1. Patients younger than 60 years of age 2. Patients who are managed non-operatively |
| Date of first enrolment | 14/01/2012 |
| Date of final enrolment | 31/08/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
Sponsor information
University/education
c/o Ms Heather House
Head of Clinical Trials Research Governance Team
Oxford
OX1 3BD
England
United Kingdom
| Phone | +44 1865 572224 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | https://www.ndorms.ox.ac.uk/research-groups/oxford-trauma |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
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 date | 01/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned 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".
