Warwick Hip Trauma Evaluation Two
| ISRCTN | ISRCTN90544391 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90544391 |
| Secondary identifying numbers | Version 3/ 16th January 2013 |
- Submission date
- 09/04/2013
- Registration date
- 09/05/2013
- Last edited
- 02/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Clinical Sciences Research Laboratories
Warwick Medical School
University Hospitals Coventry & Warwickshire
Coventry
CV2 2DX
United Kingdom
| C.A.Richmond@warwick.ac.uk |
Study information
| 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 |
| 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 total hip replacement with and without the dual mobility cup in the treatment of displaced intracapsular fractures of the proximal femur. |
| Study acronym | WHiTE Two |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2013 |
| Completion date | 01/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | All patients, males and females, over 60 years of age with a AO/OTA type B3 fracture of the proximal femur |
| Key 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) |
| Date of first enrolment | 01/05/2013 |
| Date of final enrolment | 01/05/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CV2 2DX
United Kingdom
Sponsor information
Hospital/treatment centre
Research, Development & Innovation Department
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom
| ceri.jones@uhcw.nhs.uk | |
| Website | http://www.uhcw.nhs.uk/ |
"ROR" |
https://ror.org/025n38288 |
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 02/10/2013 | Yes | No | |
| Results article | results | 01/11/2016 | Yes | No |
Editorial Notes
02/10/2018: Publication reference added
