Two year migration is comparable between all 4 groups.
ID
Bron
Aandoening
Knee replacement for painful primary or secondary osteoarthritis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
RSA migration during the first 5 years of follow-up.
Achtergrond van het onderzoek
Before 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.
Doel van het onderzoek
Two year migration is comparable between all 4 groups.
Onderzoeksopzet
3, 6 and 12 months, annually thereafter.
Onderzoeksproduct en/of interventie
Knee replacement with either a high-flex or conventional NexGen total knee prosthesis with either a fixed or mobile bearing.
Publiek
Orthopedic surgery<br>
P.O. box 9600
M.J. Nieuwenhuijse
Leiden 2300 RC
The Netherlands
+31 (0)71 5263795
M.J.Nieuwenhuijse@lumc.nl
Wetenschappelijk
Orthopedic surgery<br>
P.O. box 9600
M.J. Nieuwenhuijse
Leiden 2300 RC
The Netherlands
+31 (0)71 5263795
M.J.Nieuwenhuijse@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All suitable candidates for a Total Knee Replacement who are willing to participate in the study and follow-up.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Refusal to participate;
2. Other indications than osteoarhtritis as a reason for knee replacement.
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 | NL3143 |
| NTR-old | NTR3287 |
| Ander register | METC LUMC : p04.288 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |