The Warwick Arthroplasty Trial
| ISRCTN | ISRCTN33354155 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33354155 |
| Secondary identifying numbers | Protocol version 2 |
- Submission date
- 28/06/2007
- Registration date
- 17/09/2007
- Last edited
- 12/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Matthew Costa
Scientific
Scientific
Associate Professor Trauma and Orthopaedics Warwick Medical School
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
| Phone | +44 (0)2476 968618 |
|---|---|
| Matthew.Costa@warwick.ac.uk |
Study information
| Study design | Randomised single blind controlled trial |
|---|---|
| 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 | The Warwick Arthroplasty Trial: a randomised controlled trial of total hip arthroplasty versus resurfacing hip arthroplasty in the treatment of young patients with arthritis of the hip joint |
| Study acronym | WAT |
| Study objectives | There is no difference in hip function in patients with severe arthritis of the hip joint who have undergone a total hip arthroplasty or a resurfacing arthroplasty at one year post-operation. |
| Ethics approval(s) | Approval received from the Coventry Research Ethics Committee on the 9th May 2007 (ref: 07/Q2802/26). |
| Health condition(s) or problem(s) studied | Osteoarthritis of the hip joint |
| Intervention | 1. Patients in the Total Hip Arthroplasty group will have the head of their femur removed and replaced with a prosthetic component fixed inside the femoral shaft 2. Patients in the Hip Resurfacing Arthroplasty group will have a resurfacing cap placed upon their existing femoral head Both groups will have a new acetabular (socket) component. The details of both operative procedures will be left to the discretion of the surgeon to increase generalisabilty of the result. All patients will receive standardised rehabilitation after the operation. As part of the research patients will be followed-up for one year post-operation. Joint sponsor of this trial: University of Warwick (UK) c/o Donna McIntyre, Grants and Contracts Officer Research Support Services University House, Kirby Corner Road Coventry CV4 8UW United Kingdom Tel: +44 (0)2476 522989 Email: D.McIntyre@warwick.ac.uk |
| Intervention type | Other |
| Primary outcome measure | 1. Harris Hip Score, measured at pre-operation and 6, 12, 26 and 52 weeks post-operation 2. Oxford Hip Score, measured at pre-operation and 6, 12, 26 and 52 weeks post-operation |
| Secondary outcome measures | All secondary outcomes will be measured at pre-operation and 6, 12, 26 and 52 weeks post-operation: 1. Disability Rating Index 2. Physical activity level 3. Complication rate 4. Quality of life 5. Health economic evaluation |
| Overall study start date | 01/06/2007 |
| Completion date | 31/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 172 |
| Total final enrolment | 126 |
| Key inclusion criteria | 1. Over the age of 18 2. Able to give informed consent 3. Eligible for hip resurfacing arthroplasty |
| Key exclusion criteria | Patients with a concomitant medical problem that will preclude operation. |
| Date of first enrolment | 01/06/2007 |
| Date of final enrolment | 31/05/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Associate Professor Trauma and Orthopaedics Warwick Medical School
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Sponsor information
University Hospitals Coventry and Warwickshire NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Ceri Jones
Research and Development Department
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom
| Phone | +44 (0)2476 966196 |
|---|---|
| Ceri.jones@UHCW.nhs.uk | |
| Website | http://www.uhcw.nhs.uk/ |
"ROR" |
https://ror.org/025n38288 |
Funders
Funder type
Government
National Institute of Health Research (UK) - under the Research for Patient Benefit scheme (ref number: PB-PG-0706-10080)
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 14/01/2010 | Yes | No | ||
| Results article | 1-year results | 19/04/2012 | Yes | No | |
| Results article | 5-year results | 12/03/2018 | Yes | No |
Editorial Notes
12/01/2023: The final enrolment number has been added.
27/09/2018: publication reference added.
