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 |
| Secondary identifying numbers | N0203114899 |
- 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
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter, Devon
EX2 5BW
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 30/08/2002 |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter, Devon
EX2 5BW
United Kingdom
EX2 5BW
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Royal Devon and Exeter NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
13/10/2017: Publication reference added.
