The World Hip Trauma Evaluation Study 3: Hemiarthroplasty evaluation multi-centre investigation
| ISRCTN | ISRCTN39085558 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39085558 |
| IRAS number | 158381 |
| Secondary identifying numbers | Protocol V 2.0 24.07.14; IRAS project ID: 158381 |
- Submission date
- 23/09/2014
- Registration date
- 31/10/2014
- Last edited
- 08/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Fractures of the proximal femur (hip fractures) are a significant medical problem. The number of hip fractures is increasing and is associated with significant problems for both the patient and healthcare providers. About 40 per cent of hip fractures are intra-capsular (within the joint capsule). The blood supply to part of the hip joint is lost and a hip replacement is required. The standard treatment for many of these fractures is hip arthroplasty (replacement); either hemiarthroplasty (replacing half the hip joint) or total hip arthroplasty (replacing the whole hip joint). There is currently debate about which is the best hemiarthroplasty to use. To date, the most commonly used replacement hip implants are the Thompsons stem and the Exeter Trauma Stem. The Thompsons stem has been used extensively in the UK for over 50 years but currently does not have an Orthopaedic Device Evaluation Panel (ODEP rating), a measure of how long the implant lasts, presumably because of there is only a limited amount of information available on them. The recent guidance on hip fracture management recommends the use of proven cemented stem designs with an ODEP rating of at least 3B (97% survival at 3 years), instead of the Thompsons stem. Many clinicians believe the modern characteristics of the Exeter Trauma stem would improve the functioning of the joint after surgery. We want to find out whether there is a difference in the health of patients 4 months after being given a Thompsons Stem hip replacement compared to those given a Exeter stems hip replacement.
Who can participate?
Adults aged at least 60 with a hip fracture and needing a hip hemiarthroplasty.
What does the study involve?
Participants are randomly allocated to receive a Thompsons Stem hip replacement or a Exeter stems hip replacement. They are all asked to fill in a quality-of-life questionnaire 4 months after surgery and clinical assessments are made to compare the two implants.
What are the possible benefits and risks of participating?
There is no specific advantage for patients taking part in the study. However, the information we get from this study should help us to decide which treatment is best to use for patients with this type of injury in the future. Any operation for a hip fracture carries some risks, but they are the same for both types of hip replacement and are faced by all patients facing a hip replacement. The risks of surgery include the risk of bleeding, risk of blood clots, risk of damage to nerves and blood vessels in the surgical area and the risk associated with the anaesthetic. Patients will have routine X-rays taken of their hip before and after the operation, to evaluate the hip replacement. The dose of radiation they will receive is equivalent to around 2 months of normal background radiation and is the same for all patients who have a hip replacement for a hip fracture.
Where is the study run from?
The study takes place from the following centres in the UK:
1. Northumbria Healthcare NHS Foundation Trust
2. Newcastle Hospitals NHS Foundation Trust
3. South Tees NHS Foundation Trust
4. University Hospitals of Leicester NHS Trust.
When is study starting and how long is it expected to run for?
November 2014 to April 2016.
Who is funding the study?
Stryker (USA)
Who is the main contact?
Mr Mike Reed
mike.reed@nhs.net
Contact information
Scientific
Northumbria Healthcare NHS Foundation Trust
Woodhorn Lane
Northumberland
Northumbria
NE63 9JJ
United Kingdom
Study information
| Study design | Multi centre multi-surgeon parallel two arm standard-of-care controlled randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial comparing the Thompsons versus the Exeter® polished taper stem and Unitrax® head in the treatment of displaced intracapsular fractures of the proximal femur |
| Study acronym | WHiTE 3: HEMI |
| Study objectives | Null Hypothesis: There is no difference in health status at 4 months post injury between patients over 60 years of age with an AO/OTA type B3 fracture of the proximal femur treated with an Exeter® polished taper/Unitrax® versus a Thompsons. |
| Ethics approval(s) | NRES committee West Midlands Coventry and Warwickshire; 14/10/2014; ref. 14/WM/1098 |
| Health condition(s) or problem(s) studied | Proximal femur fractures |
| Intervention | Hip hemiarthroplasty using either Thompson prosthesis or an Exeter® polished taper with Unitrax® head |
| Intervention type | Other |
| Primary outcome measure | A validated, patient reported, quality of life questionnaire collected at 4 months post injury EQ-5D |
| Secondary outcome measures | 1. Radiological leg length discrepancy 2. Mortality 3. Re-operation and cause 4. Length of index hospital stay 5. Revision at 4 months |
| Overall study start date | 03/11/2014 |
| Completion date | 01/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 964 |
| Key inclusion criteria | All patients presenting to the collaborative with an AO/OTA type B3 fracture of the proximal femur |
| Key exclusion criteria | 1. Patients younger than 60 years of age 2. Patients with pre-existing symptomatic hip arthritis 3. Patients who are managed non-operatively 4. Patients who the responsible Consultant Orthopaedic Surgeon believe will not benefit from hemiarthroplasty |
| Date of first enrolment | 03/11/2014 |
| Date of final enrolment | 01/08/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NE63 9JJ
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Mrs Caroline Potts
Northumbria Healthcare NHS Foundation Trust
Woodhorn Lane
Northumberland
Northumbria
NE63 9JJ
England
United Kingdom
| Phone | +44 (0)191 293 4087 |
|---|---|
| caroline.potts@northumbria-healthcare.nhs.uk | |
"ROR" |
https://ror.org/01gfeyd95 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
08/03/2016: The public title has been updated from the "Warwick Hip Trauma Evaluation" to the "World Hip Trauma Evaluation 3" at the request of the principal investigator.
