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Der Rotationsstabile Schraubanker mit winkelstabiler Stützplatte (RoSA/TAP)

Erste klinische Evaluation bei instabilen trochantären Frakturen

The rotationally stable screw-anchor with trochanteric stabilizing plate (RoSA/TSP)

First results in unstable trochanteric femur fractures

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Zusammenfassung

Hintergrund

Das neuentwickelte extramedulläre Rotationsstabile Schraubanker-System (RoSA) ist einzigartig, indem es bei instabilen pertrochantären Femurfrakturen die Vorteile von Schraube und Klinge kombiniert. Mittels winkelstabiler Abstützplatte (TAP) wird nach Kompressionserzeugung unter Nutzung von Antiteleskopierschrauben das Nachsintern im Frakturbereich limitiert und die Stabilität erhöht.

Fragestellung

Ziel dieser prospektiven Kohortenstudie war die Evaluation des RoSA/TAP hinsichtlich der mechanischen Komplikationsrate und postoperativer Sinterungsvorgänge.

Methodik

Es wurden 80 instabile trochantäre Frakturen unter Verwendung des Rotationsstabilen Schraubankers (Königsee Implantate GmbH, Allendorf, Deutschland) mit additiver anatomisch geformter winkelstabiler Trochanterabstützplatte (TAP) versorgt. Je nach Instabilitätsgrad wurden, nach intraoperativer Erzeugung eines innigen Knochenkontaktes, durch das Kopfteil der Abstützplatte zusätzlich Antiteleskopierschrauben (AT-Schrauben, variabel winkelstabil, n = 1–4) konvergierend zum Kraftträger bis in das Hüftkopfzentrum eingebracht. Die postoperative Gleitstrecke des Schraubankers wurde radiologisch gemessen und die knöcherne Heilung 6–10 Wochen und 6–10 Monate postoperativ beurteilt.

Ergebnisse

Die Gleitstrecke des Schraubankers in der Gleithülsenplatte lag beim Follow-up bei den 61 (76 %) Patienten nach 6–10 Monaten bei 2mm. Insgesamt wurden 6 (8 %) ungeplante und 3 (4 %) geplant präventive Revisionseingriffe durchgeführt. Während 1/3 (4 %) der Re-Operationen aufgrund operationstechnischer Fehler in der Primär-OP erfolgten, wurden 2/3 der Eingriffe (8 %) aufgrund von knöchernen Heilungsverzögerungen (3× Pseudarthrose, 3× geplante Dynamisierungen) durchgeführt. Die Krankenhausmortalität betrug 3 % (n = 2).

Diskussion

Diese erste klinische Evaluationsstudie des Rotationsstabilen Schraubankers (RoSA/TAP) verifiziert dieses extramedulläre Implantat bei instabilen trochantären Frakturen als klinisch vielversprechend. Die Rigidität des Konstruktes stellt den Operateur vor Herausforderungen, kann aber bei Revisionsoperationen von Nutzen sein.

Abstract

Background

In unstable trochanteric fractures, the extramedullary rotationally stable screw-anchor (RoSA) combines the benefits of the load and rotational stability of the blade with the advantages of the screw (pull-out resistance, compression capability) in a single load carrier, and was designed to prevent femoral neck shortening by using an additional locked trochanteric stabilizing plate (TSP).

Objectives

The aim of the current prospective cohort study was the clinical evaluation of the RoSA/TSP system regarding the mechanical re-operation rate and the amount of postoperative femoral neck shortening.

Methods

From September 2011 to January 2014 80 patients with unstable trochanteric fractures underwent internal extramedullary fixation with the RoSA/TSP (Königsee Implantate GmbH, Allendorf, Germany). Due to fracture stability and after induction of compression, additional long locked antitelescoping screws (AT, n = 1–4) were placed reaching the femoral head. Radiological (femoral neck shortening) and clinical re-examination of patients (n = 61) was performed 6–10 weeks and 6–10 months later.

Results

In the 61 re-examined patients (76 %) femoral neck shortening was very low with 2 mm 6–10 months after operation. Re-operations occurred in 8 % (n = 6) and in 4 % (n = 3) as prophylactic surgical intervention. Whereas one-third (4 %) of re-operations occurred due to iatrogenic surgical problems from the first operation two-thirds of patients (8 %) had a re-operation due to delay of bone union (3× nonunion, 3 planned removals of AT-screws to improve healing). The in-hospital mortality was 3 % (n = 2).

Conclusions

The fixation of unstable trochanteric femur fractures using the RoSA/TSP in a first clinical setting led to a great primary stability, with significant advantages with regard to limited femoral neck shortening. However, the rigidity of the construct with its consequences regarding bone healing can be challenging for the surgeon. Nevertheless, in some cases of revision it could be beneficial for stability.

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Authors and Affiliations

  1. Abteilung für Allgemein-, Viszeral- und Unfallchirurgie, RoMed Klinik, Bad Aibling, Deutschland

    K.-J. Maier

  2. Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Gießen und Marburg GmbH, Marburg, Deutschland

    B. Bücking

  3. Klinik für Unfall- und Wiederherstellungschirurgie, Uniklinik RWTH Aachen, Pauwelsstr. 30, 52074, Aachen, Deutschland

    K. Horst, H. Andruszkow, F. Hildebrand &  M. Knobe MME

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Correspondence to M. Knobe MME.

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Interessenkonflikt

K.-J. Maier, B. Bücking, K. Horst, H. Andruszkow, F. Hildebrand und M. Knobe geben an, dass kein Interessenkonflikt besteht.

Es handelt sich um eine prospektive Kohortenstudie an Patienten, welche vorher eine Einverständniserklärung unterschrieben hatten. Alle beschriebenen Untersuchungen am Menschen wurden im Einklang mit nationalem Recht sowie gemäß der Deklaration von Helsinki von 1975 (in der aktuellen, überarbeiteten Fassung) durchgeführt. Ein positives Ethik-Votum (KEK RoMed Kliniken, EK 210/11 RWTH Aachen) liegt vor. Es wurden Behandlungsverläufe erfasst und evaluiert. Zusätzliche (experimentelle) Interventionen wurden im Rahmen der Studie nicht durchgeführt.

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Maier, KJ., Bücking, B., Horst, K. et al. Der Rotationsstabile Schraubanker mit winkelstabiler Stützplatte (RoSA/TAP). Unfallchirurg 120, 1054–1064 (2017). https://doi.org/10.1007/s00113-016-0265-2

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