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Eine neuartige Kniegelenksendoprothese mit physiologischer Gelenkform

Teil 2: Erste klinische Ergebnisse

A new total knee arthroplasty with physiologic ally shaped surfaces

Part 2: First clinical results

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Zusammenfassung

Beim Menschen ist das mediale Tibiaplateau in sagittaler Richtung konkav, das laterale aber konvex gekrümmt. Dadurch wird im Kontakt mit den konvexen Krümmungen der Femurkondylen eine physiologische Rollbewegung („roll-back“) im Kniegelenk während der Standphase induziert. Die meisten derzeit auf dem Markt erhältlichen Kniegelenksendoprothesen berücksichtigen diese morphologischen Gegebenheiten nicht.

Die neuartige Kniegelenksendoprothese AEQUOS G1 orientiert sich an den natürlichen anatomischen Gegebenheiten des Kniegelenks mit einem lateral konvexen Tibiaplateau und einem sagittalen Versatz des medialen und lateralen Kompartiments. Nach Entwicklung und umfangreicher Testung werden die ersten klinischen Ergebnisse einer Multicenterstudie mit der AEQUOS G1-Prothese vorgestellt.

Von Mai 2005 bis März 2007 wurden in vier Kliniken bei 158 Patienten, die bereit waren an der Studie teilzunehmen, eine AEQUOS G1-Kniegelenksendoprothese implantiert. Die Patienten wurden präoperativ sowie 3, 6 und 12 Monate postoperativ anhand eines standardisierten Evaluationsbogens nachuntersucht. Es wurden der American Knee Society Score (AKSS), der modifizierte Oxford Knee Score (OKS) und die visuelle Analogskala (VAS) für den Schmerz erhoben. Zu den vorgesehenen Nachuntersuchungsterminen erschienen nach 3 Monaten 151 Patienten, nach 6 Monaten waren es 134 und nach 12 Monaten 127. Das mittlere Bewegungsausmaß betrug vor der Operation 97° (±19,9°) und nach 12 Monaten 107,5° (±15,9°). Sowohl der AKSS als auch der modifizierte OKS waren nach 12 Monaten mit 165,8 (±34,0) und 21,9 (±7,8) Punkten signifikant besser als vor der Operation (95,8±35,8 und 37,7±6,9 Punkte; p<0,0001). Die VAS Schmerz war vor der Operation 7,4 (±1,8) und nach 12 Monaten 1,9 (±2,2; p<0,001) Punkte. Eine Prothese wurde aufgrund einer Arthrofibrose revidiert, eine weitere aufgrund einer Patellaluxation. Zwei Implantate wurden bei Malalignement und konsekutiver, ligamentärer Instabilität gewechselt. Infekte, aseptische Lockerungen und andere implantatspezifische Komplikationen konnten bisher nicht beobachtet werden.

Die ersten klinischen Resultate der AEQUOS G1-Prothese sind vielversprechend, Langzeitergebnisse müssen jedoch noch abgewartet werden.

Abstract

The human medial tibial plateau is concave, whereas the lateral tibial plateau is convex. In a normal knee, the convex femoral condyles roll and glide on the tibia during the standing phase of walking. The designs of most commercially available knee prostheses do not take this morphological feature into consideration.

The novel design of the AEQUOS G1 knee replacement prosthesis is based on the natural anatomy of the knee joint, with a convex lateral tibia plateau and a sagittal offset of the medial and lateral compartments. Following extensive development and testing, initial clinical results of the AEQUOS G1 prosthesis in a mulitcenter study are presented.

From Mai 2005 to March 2007, 158 patients in 4 clinics underwent total knee arthroplasty with the AEQUOS G1 and agreed to participate in the study. Patients were evaluated preoperatively and at 3, 6 and 12 months of follow-up using a standardized protocol that included the American Knee Society Score (AKSS), the Oxford Knee Score (OKS) and the Visual Analog Scale (VAS) for pain. After 3 months, 151 patients appeared for follow up appointments, after 6 months, 134, and after 12 months, 127. The mean range of motion preoperatively was 97.0° (±19.9°) and 107.5° (±15.9°) 12 months after surgery. The AKSS, as well as the modified OKS, significantly improved (p<0.0001) from preoperative scores of 98.8 (±35.8) and 37.3 (±6.9) points, respectively, to 165.8 (±34.1) and 21.9 (±7.8) points, preoperatively, and 12 months postoperatively. The VAS score significantly decreased (p<0.001) from 7.4 (±1.8) points preoperatively to 1.9 (±2.2) points 12 months postoperatively.

One implant was revised because of arthrofibrosis and another due to patellar luxation. Two patients required revision because their implants revealed malalignement with ligamentous instability. No infections, aseptic loosening or other implant-specific complications were observed at this early follow-up.

Good clinical results were observed at early follow-up with the AEQUOS G1 knee arthroplasty. However, longer follow-up is necessary for a general evaluation of the implant.

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Interessenkonflikt

Der korrespondierende Autor weist auf folgende Beziehung/en hin: Dem Autor wurden von der Firma AEQUOS Reisekosten für wissenschaftliche Vorträge erstattet.

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Authors and Affiliations

  1. Abteilung Unfallchirurgie, Plastische and Wiederherstellungschirurgie , Universitätsmedizin Göttingen , Robert-Koch-Str. 40, 37075, Göttingen, Deutschland

    K.-H. Frosch, C. Dumont & K.M. Stürmer

  2. Biomechanische Arbeitsgruppe Göttingen/Greifswald, Abteilung Kieferorthopädie, Universitätsmedizin Göttingen, Göttingen, Deutschland

    H. Nägerl

  3. Abteilung Kieferorthopädie, Universitätsmedizin Göttingen, Göttingen, Deutschland

    D. Kubein-Meesenburg  & H. Dathe

  4. Orthopädische Gemeinschaftspraxis, Northeim, Northeim, Deutschland

    J. Dörner

  5. Schreiber Klinik München, München, Deutschland

    O. Hellerer

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  1. K.-H. Frosch
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  2. H. Nägerl
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  3. D. Kubein-Meesenburg
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  4. J. Dörner
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  5. H. Dathe
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  6. O. Hellerer
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Correspondence to K.-H. Frosch.

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Frosch, KH., Nägerl, H., Kubein-Meesenburg , D. et al. Eine neuartige Kniegelenksendoprothese mit physiologischer Gelenkform. Unfallchirurg 112, 176–184 (2009). https://doi.org/10.1007/s00113-008-1551-4

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