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Prospektiv-randomisierte Studien vs. Register: Erkenntnisse für die Knorpelchirurgie am Kniegelenk

Prospective randomized clinical trials vs. registries: insights for knee cartilage repair

Zusammenfassung

Prospektiv-randomisierte klinische Studien (RCTs) gelten für die Durchführung chirurgischer Studien als Goldstandard und stehen für das höchste Evidenzlevel in der Medizin. Bedingt auch durch die Notwendigkeit von Studien für die Zulassung autologer Zelltherapien liegt im Bereich der Knorpelchirurgie eine Vielzahl prospektiv-randomisierter Studien vor. Die Durchsicht und Analyse dieser Studien bringt viele wichtige Erkenntnisse. Dennoch zeigt die Datenlage, gerade im Bereich der Knorpelchirurgie, auch die Limitationen der alleinigen Analyse prospektiv-randomisierter Studien, die viele klinisch relevante Fragestellungen nicht beantworten können. Der vorliegende Artikel diskutiert und analysiert auf Basis der Evidenzlage im Bereich der knorpelregenerativen Therapie am Kniegelenk die Vor- und Nachteile prospektiv-randomisierter Studien im Vergleich zu longitudinalen Oberservationsstudien (z. B. klinische Behandlungsregister) und plädiert für eine Adaptation der Festlegung der Evidenzlevel in Abhängigkeit der konkreten Fragestellung. Grundlage für diesen Artikel stellen die Daten aus dem KnorpelRegister DGOU dar, welches im Oktober 2013 eingeführt wurde und mittlerweile mehr als 10.000 prospektiv erfasste Datensätze beinhaltet.

Abstract

Prospective randomized clinical trials (RCTs) are considered the highest standard of clinical research and represent clinical level 1 evidence. Due to regulatory issues, there are a large number of RCTs available for cartilage repair and autologous chondrocyte implantation which revealed interesting information and contributed significantly to the existing knowledge. Nevertheless, there are also significant limitations of RCTs and many questions which are important for everyday practice cannot be sufficiently be answered by them. The current paper discusses advantages and disadvantages of RCTs versus prospective observational studies such as registries in clinical research using the example of cartilage repair of the knee including data from the German Cartilage Registry (KnorpelRegister DGOU) which was initiated in 2013 and currently contains data of more than 10,000 patients.

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Correspondence to Philipp Niemeyer.

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Niemeyer, P., Faber, S. Prospektiv-randomisierte Studien vs. Register: Erkenntnisse für die Knorpelchirurgie am Kniegelenk. Knie J. 3, 168–175 (2021). https://doi.org/10.1007/s43205-021-00113-z

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Schlüsselwörter

  • Knorpelregenerative Therapie
  • Gelenkerhalt
  • Oberservationsstudien
  • Evidenzlage
  • Limitationen

Keywords

  • Cartilage repair
  • Joint preservation
  • Observation studies
  • Evidence-based medicine
  • Limitations