RESEARCH ARTICLE


Ceramic Femoral Components in Total Knee Arthroplasty - Two Year Follow-Up Results of an International Prospective Multi-Centre Study



Philipp Bergschmidt*, 1, Rainer Bader 1, Dirk Ganzer 2, Christian Hauzeur 2, Christoph Lohmann 3, 5, Wolfgang Rüther 3, Domenico Tigani 4, Nicola Rani 4, Fernando Lopez Prats 6, Claudio Zorzi 7, Vincenzo Madonna 7, Stefano Rigotti 7, Francesco Benazzo 8, Stefano Marco Paolo Rossi 8, Guenther Kundt 9, Hans Rudolf Bloch 1, Wolfram Mittelmeier 1
1 Department of Orthopaedics, University of Rostock, Doberaner Strasse 142, 18057 Rostock, Germany
2 Department of Orthopaedics, Klinikum Neubrandenburg, Klosterberg 1a, 17087 Altentreptow, Germany
3 Department of Orthopaedics, University Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany
4 Instituti Ortopedici Rizzoli, 7: Divisione, Via Pupilli 1, 40136 Bologna, Italy
5 Department of Orthopaedics, University of Magdeburg, Leipziger Strasse 44, 39120 Magdeburg, Germany
6 Hospital General Universitario de Elche, Camino de la Azara 11, Elche, Alicante, Spain
7 Clinica Ortopedica e Traumatologica, Ospedale Sacro Cuore Don Calabria, Via Don A. Sempreboni 5, 37024 Negra (V R), Italy
8 Clinica Ortopedica e Traumatologica, I.R.C.C.S. Policlinico San Matteo, Università di Pavia, V.le Golgi 19, 27100 Pavia, Italy
9 Institute for Biostatistics and Informatics in Medicine and Ageing Research, University of Rostock, Ernst-Heydemann-Str. 8, 18057 Rostock, Germany


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© Bergschmidt et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at the Department of Orthopaedics, University of Rostock, Doberaner Str. 142, 18057 Rostock, Germany; Tel: +49-381-494-9355; Fax: +49-381-494-9303; E-mail: philipp.bergschmidt@med.uni-rostock.de


Abstract

Background:

Total knee arthroplasty can be considered as a reliable surgical procedure with a good long-term clinical result. However, implant failure due to particle induced aseptic loosening as well as the aspect of hypersensitivity to metal ions still remains an emerging issue.

Methods:

The purpose of this prospective international multi-centre study was to evaluate the clinical and radiological outcomes and the reliability of the unconstrained Multigen Plus Total Knee System with a new BIOLOX® delta ceramic femoral component. Cemented total knee arthroplasty was performed on 108 patients (110 knees) at seven hospitals in three countries. Clinical and radiological evaluations were performed preoperatively, and after 3, 12 and 24 months postoperatively using the HSS-, WOMAC-, SF-36-score and standardised X-rays.

Results:

The mean preoperative HSS-Score amounted to 55.5 ± 11.5 points and improved significantly in all postoperative evaluations (85.7 ± 11.7 points at 24 months). Furthermore, improvements in WOMAC- and SF-36-score were evaluated as significant at all points of evaluation. Radiolucent lines around the femoral ceramic component at 24 months were found in four cases. Progression of radiolucent lines was not seen and no implant loosening was observed. During the 24 month follow-up eight patients underwent subsequent surgery due to reasons unrelated to the implant material.

Conclusions:

The observed clinical and radiological results are encouraging for a long-term survival of the ceramic femoral component. Therefore, ceramic implants could be a promising solution not only for patients with allergies against metallic implant materials, but also for the osteoarthritic knee joint. Long-term follow-up is necessary to draw conclusions regarding the superiority of the ceramic knee implants concerning in vivo wear and long-term survivorship.

Keywords: Ceramics, functional outcome, radiological outcome, total knee arthroplasty.