Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
24/08/2015
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 John Timperley

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203114899

Study information

Scientific title

A randomised, controlled trial assessing the effectiveness of the iliac suction device in improving socket fixation in primary hip arthroplasty

Acronym

Study hypothesis

Does the use of an iliac suction device improve the clinical or radiological result of acetabular component survival primary total hip replacement?

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: Primary hip arthroplasty

Intervention

Patients undergoing primary total hip replacement will be randomised at the time of surgery. They will undergo the gold standard Exeter hip replacement in the usual fashion.
Half of the patients will have the iliac suction device applied at the time of socket insertion. Half of the patients will not. All will be followed up in the out-patient clinic at 6-8 weeks, 6 months, and at 1, 2, 4 and 5 year intervals. All of our usual post surgery measures will be followed. In addition, each patient will undergo radiostereometric analysis (RSA) examination at each of the attendances. At the end of 5 years, all results will be analysed and reported.

Intervention type

Device

Phase

Not Specified

Drug names

Primary outcome measures

The aim of the study is to perform a randomised controlled trial assessing the effectiveness of the iliac suction device in improving the bone-cement interface in primary total hip replacement.

Outcome measures including complications, clinical scores, gross radiological appearances and also movement assessed by the technique of RSA.

Study endpoints: Life Tables and Survival Curves with confidence limits for different definitions of failure including implant loosening and radiological evidence of failure including implant migration (as defined by RSA), excessive wear, radiolucencies etc. Log rank comparison.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/08/2002

Overall trial end date

31/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 55 and 80 years old
2. Patients undergoing uncomplicated primary hip replacement

Therapeutic research. 12 Patients in each arm of trial.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

24

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

30/08/2002

Recruitment end date

31/07/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

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

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