No registrations found.
ID
Source
Brief title
Health condition
Total hip arthroplasty; total hip prosthesis; acetabulum; cement; wear; revision.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Radiological measurements on wear patterns. It is not expected that any difference will be measurable within 5 years after surgery.
Secondary outcome
Revision for aseptic loosening, osteolysis on radiographs.
Background summary
Wear of the polyethyelene cup is a main reason for long-term failure of total hip arthroplasties. Especially in young patients, polyethylenes with high wear resistance are mandatory. In this study, we compare the wear of cups made of X3 crosslinked polyethylene versus traditional polyethyelene. At the surgical theatre, patients are randomized in two groups; traditional versus X3-cups. Except for the type of polyethyelene, all other parts of the surgery and rehabilitation are equal. Clinical and radiological follow-up will be used to determine aseptic loosening, osteolysis and wear patterns.
Study objective
Wear of the polyethyelene cup is a main reason for long-term failure of total hip arthroplasties. Especially in young patients, polyethylenes with high wear resistance are mandatory. In this study, we compare the wear of cups made of X3 crosslinked polyethylene versus traditional polyethyelene. We hypothesize that the X3 crosslinked polyethylene cups have lower wear rates and therefore longer follow-up times.
Study design
Follow-up will be done according to our standard protocol with a visit to the outward clinic at 6 weeks, 6 months, 1 years, 2 year, 3 year, 5 years, 7 years and 10 years. Both clinical data and radiological data will be recorded.
Intervention
At the surgical theatre, patients are randomly assigned into two groups; traditional versus X3 cups. Except for the type of polyethyelene cup, all other parts of the surgery and rehabilitation are equal.
Department of Orthopaedics
J. Brunnekreef
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3610810
J.Brunnekreef@fysiocss.umcn.nl
Department of Orthopaedics
J. Brunnekreef
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3610810
J.Brunnekreef@fysiocss.umcn.nl
Inclusion criteria
All patients who are younger than 50 years at time of surgery and who are planned for a primary total hip arthroplasty at the department of Orthopaedic Surgery of our University hospital are included.
Exclusion criteria
1. Patients under age of 18 years and older than 50 years;
2. Revision hip arthroplasties.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL2855 |
NTR-old | NTR2997 |
Other | CMO Nijmegen : 2010/206 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |