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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 results in https://www.ncbi.nlm.nih.gov/pubmed/18998193