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Früherkennung des Risikos der späteren Implantatlockerung mittels der Röntgen Stereophotogrammetrischen Analyse (RSA)

Early assessment of the risk of later implantloosening using Roentgen Sterophotogrammetric Analysis (RSA)

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Zusammenfassung

Hintergrund

Häufigste Ursache für Implantatrevisionen in der Hüft- und Knieendoprothetik ist die aseptische Implantatlockerung. Die Methode der Röntgen Stereophotogrammetrischen Analyse (RSA) repräsentiert den aktuellen Goldstandard zur In-vivo-Beurteilung der Implantatverankerung.

Aktuelle Stand

Klinische Langzeitstudien konnten zeigen, dass eine erhöhte und in den ersten 2 postoperativen Jahren beobachtete stetige Implantatmigration mit einer späteren aseptischen Lockerung stark korreliert. Somit ist die mit der RSA gemessene Implantatmigration als zuverlässiger Surrogatmarker für eine spätere Implantatlockerung zu betrachten. Die RSA hat sich in den letzten 40 Jahren kontinuierlich weiterentwickelt und ist durch den modellbasierten RSA-Ansatz leichter klinisch anzuwenden, da zusätzlich am Implantat angebrachte Messmarker nicht mehr benötigt werden.

Perspektiven

Der RSA-Methode kommt eine steigende Bedeutung in der Zulassung neuer Implantate zu – so wird eine verpflichtende RSA-Studie für neue Hüftimplantate von der Niederländischen Orthopädischen Gesellschaft in der klinischen Prüfung eingefordert. Auch für die im Mai 2017 in Kraft getretene neue EU-Medizinprodukteverordnung (MDR) könnte die RSA für klinisch noch unerprobte Implantate an Relevanz gewinnen. Kritikern, die mit der MDR eine Innovationsbremse assoziieren, kann entgegnet werden, dass mit der RSA-Methode eine prognostizierende Beurteilung der Implantatverankerung bereits nach einem 2‑jährigen Nachuntersuchungszeitraum gegeben werden kann, was deutlich kürzer ist als übliche klinische Langzeitstudien.

Abstract

Background

Aseptic implant loosening is the most common cause of implant revisions in total hip and total knee arthroplasty. Roentgen Stereophotogrammetric Analysis (RSA) represents the current gold standard for the in-vivo assessment of implant fixation.

Present situation

Long-term clinical trials have shown that continuous implant migration within the first two postoperative years correlates strongly with a later aseptic loosening. Thus, the implant migration measured with RSA can be regarded as a reliable surrogate marker for later implant loosening. Over the past 40 years, RSA has been continuously further developed, and the model-based RSA approach has reduced the effort involved since markers attached to implant are no longer needed.

Perspectives

The RSA method is gaining importance in the certification process of new orthopaedic implants—for example, the Dutch Orthopedic Society has recommended phased-introduction and RSA studies for new hip implants. Furthermore, in the context of the new EU Medical Device Regulation (MDR), which took effect in May 2017, RSA gained relevance for investigating clinically unproven implants. Critics who associate MDR with hindering innovation can be countered in that the RSA method provides a predictive assessment of implant fixation after only two years of follow-up, which is significantly shorter than standard long-term clinical trials.

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Abbreviations

CAD:

„Computer-aided design“

EBRA:

Ein-Bild-Röntgenanalyse

EGS:

„Elementary geometrical shapes“

ISO:

Internationale Organisation für Normung

MDR:

Medical Device Regulation

MTPM:

„Maximum total point motion“

NICE:

National Institute for Clinical Excellence

PE:

Polyethylen

PROM:

„Patient related outcome measurements“

RE:

„Reverse engineering“

RSA:

Röntgen Stereophotogrammetrische Analyse

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Danksagung

Die vorliegende Arbeit ist aus dem Clusters Implantatverankerung und -sicherheit des MSB-Net (Netzwerk Muskuloskelettale Biomechanik der Sektion Grundlagenforschung der Deutschen Gesellschaft für Orthopädie und Unfallchirurgie) entstanden.

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Authors and Affiliations

  1. Lehrstuhl für Orthopädie mit Orthopädischer Chirurgie, Orthopädische Universitätsklinik, Friedrich-Alexander-Universität Erlangen-Nürnberg, Rathsberger Straße 57, 91054, Erlangen, Deutschland

    F. Seehaus

  2. Labor für Biomechanik und Implantatforschung, Klinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Heidelberg, Heidelberg, Deutschland

    R. Sonntag & J. P. Kretzer

  3. Labor für Biomechanik und Biomaterialien, Orthopädische Klinik der Medizinischen Hochschule Hannover, Hannover, Deutschland

    M. Schwarze, E. Jakubowitz & C. Hurschler

  4. Institut für Medizintechnik, Ostbayerische Technische Hochschule Amberg-Weiden, Amberg-Weiden, Deutschland

    S. Sesselmann

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  1. F. Seehaus
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  2. R. Sonntag
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  3. M. Schwarze
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  4. E. Jakubowitz
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  5. S. Sesselmann
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  6. J. P. Kretzer
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  7. C. Hurschler
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Corresponding author

Correspondence to F. Seehaus.

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Interessenkonflikt

F. Seehaus, R. Sonntag, M. Schwarze, E. Jakubowitz, S. Sesselmann, J.P. Kretzer und C. Hurschler geben an, dass kein Interessenkonflikt besteht.

Für diesen Beitrag wurden von den Autoren keine Studien an Menschen oder Tieren durchgeführt. Für die aufgeführten Studien gelten die jeweils dort angegebenen ethischen Richtlinien.

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Seehaus, F., Sonntag, R., Schwarze, M. et al. Früherkennung des Risikos der späteren Implantatlockerung mittels der Röntgen Stereophotogrammetrischen Analyse (RSA). Orthopäde 49, 1042–1048 (2020). https://doi.org/10.1007/s00132-020-04027-y

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