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

ISRCTN	ISRCTN07813343
DOI	https://doi.org/10.1186/ISRCTN07813343
Protocol serial number	N0203114899
Sponsor	Department of Health (UK)
Funder	Royal Devon and Exeter NHS Trust (UK)

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 13/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr John Timperley
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised, controlled trial assessing the effectiveness of the iliac suction device in improving socket fixation in primary hip arthroplasty
Study objectives	Does the use of an iliac suction device improve the clinical or radiological result of acetabular component survival primary total hip replacement?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	24
Key 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.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	30/08/2002
Date of final enrolment	31/07/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Devon & Exeter Hospital (Wonford)

Exeter, Devon
EX2 5BW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/10/2017: Publication reference added.