Plain English Summary
Background and study aims
Controversy exists regarding the best treatment for independent patients with displaced intracapsular fractures of the proximal fracture. The recognised alternatives are hemiarthroplasty being used in many centres. The advantages of total hip arthroplasty (THA) are a functional benefit over hemiarthroplasty and a reduced risk of revision surgery. The principle criticism is the increased risk of dislocation. We believe that an alternative acetabular component may reduce the risk of dislocation but still provide the functional benefit of total hip arthroplasty in these patients. We therefore propose to investigate the dislocation risk of an alternative acetabular component compared with standard components in total hip arthroplasty for independent patients with displaced intracapsular fractures of the proximal femur. The aim of the study is to draw conclusions on observed differences in the dislocation risk between the study groups at one year post-injury.
Who can participate?
Any patient with an AO/OTA type B3 fracture of the proximal femur.
What does the study involve?
Eligible patients will be randomly allocated to one of two groups: standard THA or the treatment under investigation (dual mobility THA). After the procedure, all patients will be asked to complete outcome questionnaires at 1 month, 4 months and 1 year post injury. These questionnaires will be completed either by telephone or post.
What are the possible benefits and risks of participating?
Both treatments require surgery which carries some risks, but these risks are the same and equal to individuals who do not take part. The risks of surgery include the risks of bleeding, risk of deep vein thrombosis, risk of damage to nerves and blood vessels in the surgical area and the risk associated with the anaesthesia.
Where is the study run from?
The study takes place at University Hospitals Coventry and Warwickshire (UK).
When is the study starting and how long is it expected to run for?
The study is expected to start in May 2013 with recruitment expected to end in May 2014.
Who is funding the study?
Orthodynamics (UK)
Who is the main contact?
Catherine Richmond, Clinical Trial Coordinator
C.A.Richmond@warwick.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Miss Catherine Richmond
ORCID ID
Contact details
Clinical Sciences Research Laboratories
Warwick Medical School
University Hospitals Coventry & Warwickshire
Coventry
CV2 2DX
United Kingdom
C.A.Richmond@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 3/ 16th January 2013
Study information
Scientific title
A randomised controlled trial comparing total hip replacement with and without the dual mobility cup in the treatment of displaced intracapsular fractures of the proximal femur.
Acronym
WHiTE Two
Study hypothesis
The aim of this trial is to investigate the dislocation risk of a dual mobility acetabular component compared with a standard component in total hip arthroplasty for independent patients with displaced intracapsular fractures of the proximal femur.
Ethics approval
Not provided at time of registration
Study design
Single centre multi-surgeon parallel two arm standard of care controlled randomised pilot study embedded
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
Standard total hip arthroplasty or the alternative treatment a total hip arthroplasty with an acetabular component with dual mobility bearing surfaces.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Dislocation risk between the trial treatment groups at one year post injury.
Secondary outcome measures
1. EQ-5D measured at baseline, 4 weeks, 4 months and 12 months
2. ICEpop CAPability measure for Older people (ICE-CAP-O) measured at baseline, 4 weeks, 4 months and 12 months
3. Oxford Hip Score (OHS) measured at baseline, 4 weeks, 4 months and 12 months
4. Mortality
5. Re-operation and cause
6. Length of index hospital stay
7. Complications measured at baseline, 4 weeks, 4 months and 12 months
Overall trial start date
01/05/2013
Overall trial end date
01/05/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients, males and females, over 60 years of age with a AO/OTA type B3 fracture of the proximal femur
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Patients younger than 60 years of age
2. Patients with cognitive impairment
3. Patients who are being treated non-operatively
4. Those patients whose responsible Consultant Orthopaedic Surgeon believes would not benefit from THA-S (standard of care)
Recruitment start date
01/05/2013
Recruitment end date
01/05/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Sciences Research Laboratories
Coventry
CV2 2DX
United Kingdom
Sponsor information
Organisation
University Hospitals Coventry & Warwickshire (UK)
Sponsor details
Research
Development & Innovation Department
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
ceri.jones@uhcw.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Orthodynamics (UK)
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
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24089291
Publication citations
-
Protocol
Griffin XL, McArthur J, Achten J, Parsons N, Costa ML, The Warwick Hip Trauma Evaluation Two -an abridged protocol for the WHiTE Two Study: An embedded randomised trial comparing the Dual-Mobility withpolyethylene cups in hip arthroplasty for fracture., Bone Joint Res, 2013, 2, 10, 210-213, doi: 10.1302/2046-3758.210.2000186.