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Revisionsraten in Journalpublikationen zu Gelenkimplantaten mit auffällig hohen Versagensraten in Registerdatensätzen

Revision rates in journal publications on joint prostheses with noticeably high failure rates in register data sets

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Zusammenfassung

Hintergrund und Fragestellung

Der Wert von Ergebnisqualitätsdaten aus klinischen Studien wird vor dem Hintergrund von Schadensfällen kontrovers diskutiert. Ziel der Studie ist eine Darstellung und Bewertung der in klinischen Studien verfügbaren Daten zu Produkten mit schlechtem Outcome in Registern und die Möglichkeit, aus diesen Daten valide Schlussfolgerungen zu ziehen.

Studiendesign und Untersuchungsmethoden

In einer strukturierten Literaturuntersuchung wurde die Revisionsrate zu 12 Produkten, welche in Registern signifikant schlechtere Ergebnisse zeigten, verglichen. Hauptzielkriterium war die Revisionsrate aus jeder Ursache, berechnet in einer standardisierten Methodik durch „revisions per 100 observed component years“.

Ergebnisse

Zu 5 von 12 Produkten war keine einzige vergleichbare Studie verfügbar. Zu den anderen Produkten waren nur relativ wenige Daten verfügbar, eine konventionelle Metaanalyse zeigte lediglich bei 3 Produkten Ergebnisse, die mit jenen aus Registern vergleichbar waren. Bei 75% wurden gute Ergebnisse publiziert. In keinem einzigen Fall kann aus klinischen Studien alleine die Problematik, welche zu den beobachteten unterdurchschnittlichen Ergebnissen geführt hat, erkannt oder eingegrenzt werden.

Diskussion

Klinische, stichprobenbasierte Studien stellen kein taugliches und sicheres Mittel dar, um mögliche Produkt- oder Handhabungsprobleme zu erkennen und Risiken für Patienten und Ärzte zu vermeiden. Register können hierbei einen wesentlichen Beitrag leisten.

Abstract

Background and aim of study

The value of outcome quality data from clinical studies is an issue of controversial debate particularly in the context of adverse events. The aim of this study is to present and evaluate the data available from clinical studies for products that show inferior outcome in registers and to assess the possibility to draw valid conclusions from these data.

Study design and analytical methods

Based on a structured literature research, a comparative analysis was made of the revision rates of 12 products showing significantly inferior average results in registers. The primary outcome parameter was the revision rate for any reason calculated using a standardized methodology and the parameter of revisions per 100 observed component years.

Results

For 5 out of 12 products not a single comparable study was available and relatively few data were available for the remaining products. A conventional meta-analysis revealed that only three products showed results that were comparable with those from registers. For 75% of products good results were published. There was not a single case where it would have been possible to identify or isolate the problems that had led to the underperformance observed on the basis of clinical studies alone.

Discussion

Clinical sample-based studies are not a suitable and reliable means to recognize potential product or handling problems and avoid risks for patients and physicians. In this respect registers can provide an essential contribution.

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Authors and Affiliations

  1. Klinik für Orthopädie, Medizinische Universität Innsbruck, Anichstr. 35, A-6020, Innsbruck, Österreich

    G. Labek

  2. Universitätsklinik für Orthopädie und Traumatologie Pleven, Pleven, Bulgarien

    S. Todorov

  3. Orthopädische Universitätsklinik Genf, Genf, Schweiz

    A. Lübbeke-Wolff

  4. Orthopädische Abteilung, Bezirkskrankenhaus St. Johann in Tirol, St. Johann in Tirol, Österreich

    B. Haderer

  5. Orthopädische Universitätsklinik Martin, Martin, Slowakei

    S. Krivanek

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  1. G. Labek
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  2. S. Todorov
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  3. A. Lübbeke-Wolff
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  4. B. Haderer
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  5. S. Krivanek
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Correspondence to G. Labek.

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Labek, G., Todorov, S., Lübbeke-Wolff, A. et al. Revisionsraten in Journalpublikationen zu Gelenkimplantaten mit auffällig hohen Versagensraten in Registerdatensätzen. Orthopäde 41, 853–859 (2012). https://doi.org/10.1007/s00132-012-1945-4

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