Condition category
Musculoskeletal Diseases
Date applied
28/06/2007
Date assigned
17/09/2007
Last edited
31/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Matthew Costa

ORCID ID

Contact details

Associate Professor Trauma and Orthopaedics Warwick Medical School
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 (0)2476 968618
Matthew.Costa@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol version 2

Study information

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

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.

Ethics approval

Approval received from the Coventry Research Ethics Committee on the 9th May 2007 (ref: 07/Q2802/26).

Study design

Randomised single blind controlled trial

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

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/06/2007

Overall trial end date

31/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Over the age of 18
2. Able to give informed consent
3. Eligible for hip resurfacing arthroplasty

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

172

Participant exclusion criteria

Patients with a concomitant medical problem that will preclude operation.

Recruitment start date

01/06/2007

Recruitment end date

31/05/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Associate Professor Trauma and Orthopaedics Warwick Medical School
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University Hospitals Coventry and Warwickshire NHS Trust (UK)

Sponsor details

c/o Ceri Jones
Research and Development Department
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 (0)2476 966196
Ceri.jones@UHCW.nhs.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

National Institute of Health Research (UK) - under the Research for Patient Benefit scheme (ref number: PB-PG-0706-10080)

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20074324
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22517930

Publication citations

  1. Results

    Achten J, Parsons NR, Edlin RP, Griffin DR, Costa ML, A randomised controlled trial of total hip arthroplasty versus resurfacing arthroplasty in the treatment of young patients with arthritis of the hip joint., BMC Musculoskelet Disord, 2010, 11, 8, doi: 10.1186/1471-2474-11-8.

  2. Results

    Costa ML, Achten J, Parsons NR, Edlin RP, Foguet P, Prakash U, Griffin DR, , Total hip arthroplasty versus resurfacing arthroplasty in the treatment of patients with arthritis of the hip joint: single centre, parallel group, assessor blinded, randomised controlled trial., BMJ, 2012, 344, e2147.

Additional files

Editorial Notes