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…
ID
Bron
Verkorte titel
Aandoening
Total hip arthroplasty; total hip prosthesis; acetabulum; cement; wear; revision.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Radiological measurements on wear patterns. It is not expected that any difference will be measurable within 5 years after surgery.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
Department of Orthopaedics
J. Brunnekreef
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3610810
J.Brunnekreef@fysiocss.umcn.nl
Wetenschappelijk
Department of Orthopaedics
J. Brunnekreef
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3610810
J.Brunnekreef@fysiocss.umcn.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patients under age of 18 years and older than 50 years;
2. Revision hip arthroplasties.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2855 |
NTR-old | NTR2997 |
Ander register | CMO Nijmegen : 2010/206 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |