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
| ISRCTN | ISRCTN53483743 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53483743 |
| Secondary identifying numbers | N0203162871 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 04/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
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, 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 17/03/2005 |
| Completion date | 16/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 322 |
| Key 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 |
| Key exclusion criteria | 1. Age > 65 2. No informed consent |
| Date of first enrolment | 17/03/2005 |
| Date of final enrolment | 16/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
EX2 5DW
United Kingdom
Sponsor information
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
No information available
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 |
Editorial Notes
04/03/2016: Plain English summary added.
