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Migration of the NexGen Total Knee Prosthesis: A 4-arm RCT comparing.


- candidate number11133
- NTR NumberNTR3287
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-feb-2012
- Secondary IDsp04.288 METC LUMC
- Public TitleMigration of the NexGen Total Knee Prosthesis: A 4-arm RCT comparing.
- Scientific TitleA 4-arm clinical and RSA randomized trial comparing migration of the high flex versus conventional with either fixed or mobile bearing Nexgen Total Knee Prosthesis.
- ACRONYM
- hypothesisTwo year migration is comparable between all 4 groups.
- Healt Condition(s) or Problem(s) studiedProthesis, Knee, Osteoarthritis
- Inclusion criteriaAll suitable candidates for a Total Knee Replacement who are willing to participate in the study and follow-up.
- Exclusion criteria1. Refusal to participate;
2. Other indications than osteoarhtritis as a reason for knee replacement.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2002
- planned closingdate1-sep-2012
- Target number of participants60
- InterventionsKnee replacement with either a high-flex or conventional NexGen total knee prosthesis with either a fixed or mobile bearing.
- Primary outcomeRSA migration during the first 5 years of follow-up.
- Secondary outcomeFunction, Knee Society Score, Complications.
- Timepoints3, 6 and 12 months, annually thereafter.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. M.J. Nieuwenhuijse
- CONTACT for SCIENTIFIC QUERIESMD. M.J. Nieuwenhuijse
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryBefore widespread introduction to the market, new prosthesis designs or related developments, the intitial performance should be evaluated using Roentgen Stereophotogrammetric Analysis (RSA). This highly accurate measurement technique determines the initial migration, and thus fixation, of prostheses, which has been shown to be predictive of long-term survivorship. This study is a 4-arm randomized controlled trial which compares the clinical outcome and migration (RSA) of a conventional NexGen Total Knee Posthesis (TKP) with the newly introduced high-flex NexGen TKP, both designs have either a mobile or fixed bearing.
- Main changes (audit trail)
- RECORD14-feb-2012 - 2-mrt-2012


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