| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN33354155 |
| Date ISRCTN assigned | 17/09/2007 |
| Local reference number(s) | Protocol version 2 |
| Public title | The Warwick Arthroplasty Trial |
| 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 |
| Acronym | WAT |
| Disease/condition/study domain | Osteoarthritis of the hip joint |
| Study hypothesis | 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. |
| Design/methodology | A randomised, single blind, controlled trial |
| Research ethics review | Approval received from the Coventry Research Ethics Committee on the 9th May 2007 (ref: 07/Q2802/26). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Over the age of 18
2. Able to give informed consent
3. Eligible for hip resurfacing arthroplasty |
| Participants - exclusion criteria | Patients with a concomitant medical problem that will preclude operation. |
| Patient information material |
|
| Anticipated start date | 01/06/2007 |
| Anticipated end date | 31/05/2010 |
| Status of trial | Ongoing |
| Target number of participants | 172 |
| Interventions | 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 |
| Primary outcome measure(s) | 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 measure(s) | 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 |
| Sources of funding | National Institute of Health Research (UK) - under the Research for Patient Benefit scheme (ref number: PB-PG-0706-10080) |
| Sponsor name | University Hospitals Coventry and Warwickshire NHS Trust (UK) |
| Sponsor details | c/o Ceri Jones
Research and Development Department
Clifford Bridge Road
Coventry
United Kingdom
CV2 2DX |
| Sponsor telephone | +44 (0)2476 966196 |
| Sponsor email | Ceri.jones@UHCW.nhs.uk |
| Sponsor website | http://www.uhcw.nhs.uk/ |
| Contact name | Mr Matthew Costa |
| Contact details | Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
United Kingdom
CV2 2DX |
| Contact telephone | +44 (0)2476 968618 |
| Contact email | Matthew.Costa@warwick.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN33354155 |
| Date last extracted from ISRCTN register | 17/04/2008 |
