Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
04/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A hip replacement is a common type of surgery where a damaged hip joint is replaced with an artificial one. The aim of this study is to determine the most appropriate type of hip replacement to be used in the younger, higher demand patient undergoing total hip replacement.

Who can participate?
Patients aged under 65 undergoing primary total hip replacement.

What does the study involve?
Participants are randomly allocated to receive one of two types of hip replacement: either an uncemented ceramic-on-ceramic bearing socket or a standard metal-on-polyethylene cemented socket. Revision rates are then compared between the two groups (i.e., does one group have to have their hip replacements re-done either earlier or more frequently than the other).

What are the possible benefits and risks of participating?
If a significant benefit is found in one group compared to the other, this practice could be adopted across the Hip Unit in primary total hip replacement in patients under 65 years old.

Where is the study run from?
The Princess Elizabeth Orthopaedic Centre (UK)

When is the study starting and how long is it expected to run for?
March 2005 to March 2020

Who is funding the study?
1. Royal Devon and Exeter NHS Trust (UK)
2. NHS R&D Support Funding (UK)

Who is the main contact?
John Timperley

Trial website

Contact information

Type

Scientific

Primary contact

Mr John Timperley

ORCID ID

Contact details

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203162871

Study information

Scientific title

A randomised, prospective, single blind study comparing a standard metal on polyethylene cemented socket in primary hip replacement versus an uncemented ceramic on ceramic bearing socket in patients under 65 years old

Acronym

Study hypothesis

Which is the optimum bearing surface for hip replacements in the younger, high demand patient-metal on polyethyene or ceramic on ceramic? The aim of the study is to provide an evidence base regarding the most appropriate type of hip replacement to be used in the younger, higher demand patient undergoing total hip replacement. If significant benefit is found in one arm of the trial compared to the other, this practice would be adopted across the Hip Unit in primary THR in patients under 65 years old.

Ethics approval

Not provided at time of registration

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

Surgery: Hip replacement

Intervention

A randomised, prospective, blinded clinical trial is to be set up to compare the effect of an uncemented ceramic on ceramic bearing versus a cemented socket with a metal on polyethylene articulation in primary total hip replacement in patients under 65 years old. The study will be carried out in both the wards and out-patient clinics of the Princess Elizabeth Orthopaedic Centre. Patients will be approached at the pre-assessment clinic and offered the opportunity to be involved in the research. Surgeons will consent the patients re this study. Informed written consent to partake will be mandatory for inclusion and any patient who declines will be excluded. Patients who agree to enter the study will be divided at random to enter different arms of the study. 161 patients to be initially included into each group with allocation to either arm of the trial by drawing appropriately marked slips of paper from an opaque envelope. The surgeon will not be able to read the slips before they are drawn. Various outcome measures will be used including the need for re-operation for any reason, development of osteolysis, development of aseptic cup loosening, component failure, dislocation, Oxford and Harris hip scores and the modified Charnley scoring system.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Comparison of revision rates ie does one group have to have their hip replacements re-done either earlier or more frequently than the other.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

17/03/2005

Overall trial end date

16/03/2020

Reason abandoned

Eligibility

Participant inclusion criteria

Any patient admitted by the Hip Unit surgeons about to undergo primary total hip replacement, aged under 65 and who has given informed consent to take part

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

322

Participant exclusion criteria

1. Age > 65
2. No informed consent

Recruitment start date

17/03/2005

Recruitment end date

16/03/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Devon and Exeter NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (UK)

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

Publication citations

Additional files

Editorial Notes

04/03/2016: Plain English summary added.