Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol V 2.0 24.07.14; IRAS project ID: 158381
Study information
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
Acronym
WHiTE 3: HEMI
Study hypothesis
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
NRES committee West Midlands Coventry and Warwickshire; 14/10/2014; ref. 14/WM/1098
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
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Proximal femur fractures
Intervention
Hip hemiarthroplasty using either Thompson prosthesis or an Exeter® polished taper with Unitrax® head
Intervention type
Other
Phase
Not Applicable
Drug names
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 trial start date
03/11/2014
Overall trial end date
01/08/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients presenting to the collaborative with an AO/OTA type B3 fracture of the proximal femur
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
964
Participant 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
Recruitment start date
03/11/2014
Recruitment end date
01/08/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northumbria Healthcare NHS Foundation Trust
Northumbria
NE63 9JJ
United Kingdom
Sponsor information
Organisation
Northumbria Healthcare NHS Foundation Trust (UK)
Sponsor details
c/o Mrs Caroline Potts
Northumbria Healthcare NHS Foundation Trust
Woodhorn Lane
Northumberland
Northumbria
NE63 9JJ
United Kingdom
+44 (0)191 293 4087
caroline.potts@northumbria-healthcare.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Stryker® (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list