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Vergelijkende studie naar slijtage van polyethyleen van heupprothesen bij jonge patiŽnten.


- candidate number10165
- NTR NumberNTR2997
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2011
- Secondary IDs2010/206 CMO Nijmegen
- Public TitleVergelijkende studie naar slijtage van polyethyleen van heupprothesen bij jonge patiŽnten.
- Scientific TitleA prospective randomized study on wear in young patients: Traditional polyethylene versus X3 crosslinked polyethyelene.
- ACRONYMX3-trial
- hypothesisWear 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.
- Healt Condition(s) or Problem(s) studiedCement, Total Hip Arthroplasty, Total hip prosthesis, Acetabulum, Wear, Revision
- Inclusion criteriaAll 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 criteria1. Patients under age of 18 years and older than 50 years;
2. Revision hip arthroplasties.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-okt-2010
- planned closingdate1-okt-2012
- Target number of participants60
- InterventionsAt 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.
- Primary outcomeRadiological measurements on wear patterns. It is not expected that any difference will be measurable within 5 years after surgery.
- Secondary outcomeRevision for aseptic loosening, osteolysis on radiographs.
- TimepointsFollow-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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J. Brunnekreef
- CONTACT for SCIENTIFIC QUERIES B.W. Schreurs
- Sponsor/Initiator Radboud University Nijmegen Medical Centre, Department of Orthopaedics
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- PublicationsN/A
- Brief summaryWear 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.
- Main changes (audit trail)
- RECORD15-jul-2011 - 2-sep-2011


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