World hip trauma evaluation five: a randomised controlled trial comparing cemented and uncemented implants for the treatment of displaced intracapsular hip fractures
| ISRCTN | ISRCTN18393176 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18393176 |
| Secondary identifying numbers | 32748 |
- Submission date
- 13/03/2017
- Registration date
- 16/03/2017
- Last edited
- 26/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
A hip fracture is where there is a break in the upper thigh bone (femur). They are very common affecting around 60,000 people each year, particularly in older adults. A hip fracture is a potentially catastrophic event, with approximately 30% of patients dying within a year of the injury and the rest experiencing a significant reduction in their quality of life. The most common type of hip fracture is treated with a partial hip replacement or hemi-arthroplasty. The hemi-arthroplasty can be fixed to the patient’s thigh bone with or without the use of ‘bone cement’. Cement is the current standard technique, but there are some risks with bone cement which could be avoided by using ‘uncemented’ implants. These risks, which include an increased risk of death during the first 24 hours after surgery, have prompted a recent alert from the National Patient Safety Agency. Traditionally, early types of uncemented implants led to worse outcomes for patients compared to cemented implants. Now however, there have been significant improvements in uncemented implant technology and the current, limited evidence suggests that these modern implants may be as good as the cemented implants but without the risks of using cement. The aim of this study is test whether there are differences in patients’ quality of life following treatment with one of these hemiarthroplasty implants. The study will also test whether one treatment is more cost-effective than the other, and whether either treatment impacts on blood pressure.
Who can participate?
Patients aged 60 and older who have fractured their hip and will receive treatment with a hemiarthroplasty
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group undergo surgery to fix their hip fracture using traditional cemented implants. Those in the second group undergo surgery to fix their hip fracture using modern uncemented hemiarthroplasty implants. Following fixation of their hip fracture, all patients undergo a routine rehabilitation before they are discharged from hospital. Patients or their carers are asked to complete a questionnaire to assess their quality of life at the start of the study, and then 4 weeks, 4 months and 12 months later. In addition some routinely collected data is sent to the study team, including notes about the operation, discharge details, and blood pressure measurements taken during surgery. After completing the 12-month questionnaire, patients have completed their participation in the study and continue to be treated as per normal standard of care.
What are the possible benefits and risks of participating?
There is no specific advantage to taking part in the study. However, the information from this trial will help provide information about which treatment is best for patients with this type of injury. Any operation for a broken hip carries some risks. The risks of surgery with both implants include: bleeding, infection, further fracture, dislocation, leg length discrepancy, blood clots, damage to nerves and blood vessels, and the risks associated with the anaesthetic. These risks are the same as for patients who are not part of this research project. There are also uncommon risks associated with each type of hip replacement. In a small number of cases, patients having a cemented replacement can have a reaction to the bone cement, and in a small number of uncemented replacements there may be an extension of the fracture during surgery. If either event were to occur, the anaesthetist and surgeon would continue treatment as per normal practice.
Where is the study run from?
1. University Hospital Coventry (UK)
2. Royal Berkshire Hospital (UK)
3. Queen Alexandra Portsmouth (UK)
4. Queen Elizabeth Hospital (UK)
5. John Radcliffe Hospital (UK)
6. Gloucestershire Royal Hospital (UK)
7. Heartlands Hospital (UK)
8. Lincoln County Hospital (UK)
9. Pilgrim Hospital, Boston (UK)
10. Royal Lancaster Infirmary (UK)
11. Royal London Hospital (UK)
12. Southport Hospital (UK)
13. Warwick Hospital (UK)
When is the study starting and how long is it expected to run for?
September 2016 to January 2021 (updated 09/12/2020, previously: December 2020 (updated 10/12/2019, previously: October 2020))
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Mrs Katy Mironov (public)
white5@ndorms.ox.ac.uk
2. Professor Matthew Costa (scientific)
matthew.costa@ndorms.ox.ac.uk
Contact information
Public
Oxford Trauma
Kadoorie Research CentreJohn Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0002-8372-8181 |
|---|---|
| Phone | +44 (0)1865 227912 |
| white5@ndorms.ox.ac.uk |
Scientific
Orthopaedic and Trauma Surgery
University of Oxford, NDORMS
Kadoorie Centre
Level 3, John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
| ORCID ID |
0000-0003-3644-1388 |
|---|---|
| Phone | +44 (0)1865 223114 |
| matthew.costa@ndorms.ox.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Device, Surgery |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN18393176_PIS_30Jul18_V3.pdf |
| Scientific title | A randomised controlled trial to compare contemporary un-cemented hemiarthroplasty with the standard-of-care cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures |
| Study acronym | WHiTE Five |
| Study hypothesis | Feasibility study: The aim of this study is to establish the feasibility of conducting a full-scale trial comparing cemented with modern uncemented hemiarthroplasty implants. Main phase of the study (added 11/04/2018): The aim of this randomised controlled trial is to compare the health-related quality of life in participants over 60 years of age with a displaced intracapsular hip fracture receiving contemporary uncemented hemiarthroplasty versus the current standard-of-care cemented hemiarthroplasty. |
| Ethics approval(s) | 1. Feasibility study: Wales Research Ethics Committee 5, 02/12/2016, ref: 16/WA/0351 2. Main phase: Wales Research Ethics Committee 5, 22/11/2017, ref: 17/WA/0383 |
| Condition | Hip fracture |
| Intervention | Patients will be randomly assigned a treatment using a web-based randomisation system, this will make sure that about the same number of patients in each participating hospital are assigned each treatment. Patients will then undergo surgery at the next available opportunity on a planned trauma list. The exact surgical procedures will be as per local guidelines. Following surgery patients will undergo a routine rehabilitation programme as per local guidelines. Cemented hemiarthroplasty: the neck and head of the femur will be replaced with a cemented femoral stem. This is the current standard of care in many UK hospitals Uncemented hemiarthroplasty: the neck and head of the femur will be replaced with a modern (contemporary) uncemented femoral stem. Uncemented stems are already used as standard practice in some UK hospitals. Feasibility study: Participants will be asked to complete a questionnaire during their initial stay in hospital, 1 month after their operation, and 4 months after their operation. This will usually be done in-person or over the telephone, and may be sent by post. If the patient is unable to answer the questions then an appropriate consultee will be asked to answer on the patient’s behalf. The short questionnaire is about quality of life before and after the injury, and the amount of care the patient receives. Main phase of the study (added 11/04/2018): Participants will be asked to complete a questionnaire during their initial stay in hospital, and 1, 4 and 12 months after their operation. This will usually be done in-person or over the telephone, and may be sent by post. If the patient is unable to answer the questions then an appropriate consultee will be asked to answer on the patient’s behalf. The short questionnaire is about quality of life before and after the injury, and the amount of care the patient receives. Some hospitals will contribute intraoperative and post-operative haemodynamic measurements for enrolled patients. These will be used to determine the feasibility of collecting this data on a larger scale, and to assess any observed difference in haemodynamic parameters between groups. |
| Intervention type | Other |
| Primary outcome measure | Feasibility study: Recruitment rate, calculated from the number of patients screened and recruited at each participating hospital. Logs of screened and recruited patients monitored monthly. Main phase of the study (added 11/04/2018): Quality of life, measured using the EQ-5D-5L score at 4 months post-randomisation |
| Secondary outcome measures | Feasibility study: 1. Quality of life, measured using the EQ-5D-5L questionnaire at baseline (retrospective/pre-injury), 1 month and 4 months after surgery 2. Trial feasibility, assessed by analysing the reasons given by potential patients who chose not to participate (or who later withdraw), monitored continuously throughout the trial 3. Changes in blood pressure during and immediately after surgery, calculated from routinely collected blood pressure measurements Main phase of the study (added 11/04/2018): 1. Quality of life, measured using the EQ-5D-5L at 1 and 12 months post randomisation 2. Mortality, measured using routine NHS data at 1, 4 and 12 months post randomisation 3. Functional status, patient-reported during follow-up at 1, 4 and 12 months post randomisation 4. Incidence and cause of revision surgery, patient-reported and from hospital records during follow-up at 12-months post randomisation 5. Complication profile, patient-reported during follow-up at 12-months post randomisation 6. Residential status, patient-reported during follow-up at 1, 4 and 12 months post randomisation 7. Resource use, patient-reported and from hospital records during follow-up at 12-months post randomisation 8. Blood pressure changes during surgery measured using intra-operative haemodynamic measurements at baseline |
| Overall study start date | 01/09/2016 |
| Overall study end date | 31/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1128; UK Sample Size: 1128 |
| Total final enrolment | 1125 |
| Participant inclusion criteria | Feasibility study: All patients, both those with and without capacity, presenting with an AO type 31-B3 (subcapital, displaced, nonimpacted) fracture of the hip Main phase of the study (added 11/04/2018): All patients aged 60 years and older who have fractured their hip and will receive treatment with a hemiarthroplasty |
| Participant exclusion criteria | 1. Younger than 60 years of age 2. Managed non-operatively 3. Treated with a total hip replacement |
| Recruitment start date | 10/03/2017 |
| Recruitment end date | 04/12/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Coventry
CV2 2DX
United Kingdom
Reading
RG1 5AN
United Kingdom
Portsmouth
PO6 3LY
United Kingdom
Birmingham
B15 2TH
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Slough
SL2 4HL
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Birmingham
B9 5SS
United Kingdom
Lincoln
LN2 5QY
United Kingdom
Boston
PE21 9QS
United Kingdom
Bromley Corridor
Ashton Road
Lancaster
LA1 4RP
United Kingdom
London
E1 1BB
United Kingdom
PR8 6PN
United Kingdom
Warwick
CV34 5BW
United Kingdom
Slough
SL2 4HL
United Kingdom
Sponsor information
Hospital/treatment centre
Clinical Trials and Research Governance
Joint Research Office
Block 60
Churchill Hospital
Headington
Oxford
OX3 7LE
England
United Kingdom
| Phone | +44 (0)1865 572221 |
|---|---|
| ctrg@admin.ox.ac.uk | |
"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 | 31/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | The results of this trial will be disseminated to the hip fracture clinical community via presentations at national and international meetings as well as publication in peer reviewed journals. |
| IPD sharing plan | Current IPD sharing statement as of 22/11/2021: The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. _____ Previous IPD sharing statement: The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V3 | 30/07/2018 | 05/08/2019 | No | Yes |
| Protocol article | protocol | 09/12/2019 | 01/12/2020 | Yes | No |
| Results article | 10/02/2022 | 10/02/2022 | Yes | No | |
| Other publications | Economic evaluation plan | 13/03/2020 | 26/04/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN18393176_PIS_30Jul18_V3.pdf
- Uploaded 05/08/2019
Editorial Notes
26/04/2023: Publication reference added.
10/02/2022: Publication reference added.
22/11/2021: The IPD sharing statement has been changed.
12/11/2021: The intention to publish date has been changed from 01/05/2021 to 31/05/2022.
09/12/2020: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2020 to 31/01/2021.
2. The plain English summary was updated to reflect these changes.
01/12/2020: Publication reference added.
15/01/2020: The total final enrolment number has been changed from 1228 to 1225.
10/12/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/11/2019 to 04/12/2019.
2. The overall end date was changed from 31/10/2020 to 31/12/2020.
3. The intention to publish date was changed from 01/03/2021 to 01/05/2021.
4. The total final enrolment was added.
5. The plain English summary was updated to reflect these changes.
05/08/2019: The new participant information sheet has been uploaded.
02/08/2019: The following changes were made to the trial record:
1. Trial participating centres added.
2. The recruitment end date was changed from 30/09/2019 to 01/11/2019.
3. The intention to publish date was changed from 28/02/2019 to 01/03/2021.
4. Contact details updated.
26/03/2019: The condition has been changed from "Specialty: Injuries and emergencies, Primary sub-specialty: Musculoskeletal Trauma; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the hip and thigh" to "Hip fracture" following a request from the NIHR.
11/04/2018: The following changes were made to the trial record:
1. The scientific title was changed from 'World hip trauma evaluation five: a feasibility study comparing cemented and uncemented implants for the treatment of hip fractures' to 'World hip trauma evaluation five: a randomised controlled trial comparing cemented and uncemented implants for the treatment of displaced intracapsular hip fractures'.
2. The public title was changed from 'A feasibility study to compare contemporary un-cemented hemiarthroplasty with the standard-of-care cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures' to 'A randomised controlled trial to compare contemporary un-cemented hemiarthroplasty with the standard-of-care cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures'.
3. John Radcliffe Hospital, King’s Mill Hospital, Sandwell General Hospital, Wexham Park Hospital, and Blackpool Victoria Hospital were added to the trial participating centres.
4. The hypothesis, ethics approval, interventions, primary and secondary outcome measures and inclusion criteria were updated.
5. The recruitment end date was changed from 31/08/2017 to 30/09/2019.
6. The overall trial end date was changed from 28/02/2018 to 31/10/2020.
7. The target number of participants was changed from 100 to 1128.
09/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.
