Condition category
Musculoskeletal Diseases
Date applied
21/03/2005
Date assigned
14/04/2005
Last edited
10/05/2016
Prospective/Retrospective
Prospectively 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 Fares Haddad

ORCID ID

Contact details

Princess Grace Hospital
42-52 Nottingham Place
London
W1U 5NY
United Kingdom
+44 (0)20 7935 6083
fareshaddad@aol.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04/Q0505/71

Study information

Scientific title

Improving the bearing surface in total hip replacement (THR): the use of oxidised zirconium and highly cross-linked polyethylene - a randomised controlled trial

Acronym

Study hypothesis

Does the use of oxidised zirconium femoral heads in total hip replacement reduce the rate of volumetric and linear wear as compared to conventional material heads, whilst providing comparable outcome measures?

Ethics approval

Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A), 14/01/2005, ref: 04/Q0505/71

Study design

Randomised 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

Arthritis of the hip

Intervention

Primary total hip replacement, using either cobalt chrome or oxinium femoral heads and either standard or highly cross-linked polyethylene liners.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Radiographic wear; measuring linear & volumetric wear based on standardised AP & lateral radiographs of the pelvis then analysed with an automated edge detection technique

Secondary outcome measures

Not provided at time of registration

Overall trial start date

14/01/2009

Overall trial end date

01/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. The patient and surgeon agree that primary THR is necessary
2. The patient is 18 years of age or older (either sex) on the day of signing the Study Consent Form
3. The patient is capable of participating in the study:
3.1. Fluent in English, or has a capable proxy
3.2. Mentally intact
3.3. Emotionally stable
3.4. A permanent resident in an area accessible to the study site

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Current medical conditions such as:
1.1. Metastatic or primary tumor of the hip
1.2. Implantation into a previously resected hip (i.e. conversion to THR)
1.3. Neurologic deficit impairing the affected limb
2. History of medical conditions such as:
2.1. Septic arthritis in the affected hip
2.2. Reflex sympathetic dystrophy of the affected leg
2.3. Progressive muscular condition causing deterioration of the abductor muscles
2.4. Hip pain associated with back pathology such as spinal stenosis or vascular occlusion

Recruitment start date

14/01/2009

Recruitment end date

01/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Princess Grace Hospital
London
W1U 5NY
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Trust (UK)

Sponsor details

The Middlesex Hospital
Mortimer Street
London
W1T 3AA
United Kingdom
+44 (0)20 7380 9413
fareshaddad@aol.com

Sponsor type

University/education

Website

http://www.uclh.nhs.uk/

Funders

Funder type

Industry

Funder name

Smith & Nephew (UK) - discretionary grant to fund salary of MD student only

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26130341

Publication citations

Additional files

Editorial Notes

10/05/2016: Publication reference added. 11/02/2009: The overall trial start date was changed from 01/09/2004 to 14/01/2009.