Condition category
Surgery
Date applied
09/04/2013
Date assigned
09/05/2013
Last edited
07/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.uhcw.nhs.uk/

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

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24089291

Publication citations

  1. 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.

Additional files

Editorial Notes