Dokument

Zusammenfassung:
Hintergrund: Mobilen Tibiainlays in der Knieendoprothetik werden theoretische Eigenschaften bescheinigt, die zu verbesserten funktionellen Ergebnissen und auf längere Sicht zu reduziertem Polyethylenabrieb führen sollen. Diese Studie untersuchte kurzfristige klinische Resultate von zwei Patientengruppen, die sich systematisch lediglich in der Art der verwendeten Tibiaplattform unterschieden. Eine Gruppe erhielt ein fixiertes Inlay, während der anderen ein mobiles implantiert wurde. Methoden: 100 Kniegelenke bei 97 Patienten wurden gemäß ihres Alters sowie nach ihrem Geschlecht stratifiziert und in zwei Gruppen randomisiert: fixed-bearing (FB) mit 52 Kniegelenken und rotating platform (RP) mit 48 Kniegelenken. Alle Patienten erhielten den das hintere Kreuzband erhaltenden bikondylären Oberflächenersatz Columbus® (B. Braun Aesculap, Tuttlingen, Germany) mit entweder festem oder rotierendem Polyethylen-Inlay. Die Prozeduren wurden von zwei erfahrenen Operateuren durchgeführt, und die Gruppen folgten einem identischen Rehabilitationsschema. Klinische Nachuntersuchungen fanden in doppelt verblindeter Art vor der Operation sowie drei, sechs und zwölf Monate danach statt. Zur klinischen Bewertung wurden der wissenschaftlich etablierte Knee Society Score (KSS) und der Oxford Knee Score (OKS) verwendet. Bei der statistischen Auswertung kamen der Mann-Whitney-U-Test mit alpha = 0,05 und beta = 0,15 für den primären Endpunkt eines als klinisch relevant angenommen KSS-Unterschiedes von mehr als acht Punkten zur Anwendung sowie Varianzanalysen (ANOVA) für das explorative Testen des Einflusses der Ausgangswerte der Scores als Kovariaten und der Nachuntersuchungszeitpunkte auf die Resultate. Ergebnisse: Der primäre Endpunkt des KSS sowie die sekundären Endpunkte des OKS und der range of motion (ROM) waren zwischen den Gruppen nicht statisch signifikant unterschiedlich. Sowohl die demographischen Daten der Untersuchungsgruppen als auch deren radiologisches Alignment prä- und postoperativ zeigten sich homogen. Wurden bei der statistischen Analyse die präoperativen Ausgangswerte der Scores als Kovariaten mit einbezogen und deren Einfluss untersucht, so ließen sich ebenfalls keine signifikanten Differenzen zwischen den Gruppen nachweisen. Schlussfolgerung: In unserer Untersuchung zeigte sich kein Unterschied im KSS von mehr als acht Punkten im ersten Jahr nach der Operation zwischen der FB- und der RP-Gruppe beim bikondylären Kniegelenkoberflächenersatz. Das Studiendesign kontrollierte darüber hinaus auf diverse andere Differenzen zwischen den Gruppen sowie den Einfluss zusätzlicher Variablen neben der Art des Tibiainlays auf die Ergebnisse. Auch dabei ließen sich keine signifikanten Unterschiede nachweisen. Hinsichtlich des ersten postoperativen Jahres und für Patienten, die unsere Einschlusskriterien erfüllten, konnte dementsprechend kein Vorteil für weder die fixierte noch die mobile Tibiaplattform herausgestellt werden. Es liegt nach den aktuellen wissenschaftlichen Erkenntnissen demnach kein schlüssiges Argument vor, eines der beiden Implantatdesigns zu bevorzugen.

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