Philipp Bergschmidt1, Rainer Bader2, Dirk Ganzer3, Christian Hauzeur3, Christoph H Lohmann4, Alexander Krüger4, Wolfgang Rüther5, Domenico Tigani6, Nicola Rani6, José Luis Esteve7, Fernando Lopez Prats7, Claudio Zorzi8, Vincenzo Madonna8, Stefano Rigotti8, Francesco Benazzo9, Stefano Marco Paolo Rossi9, Wolfram Mittelmeier2. 1. Department of Orthopaedics, University Medicine Rostock, Doberaner Strasse 142, Rostock 18057, Germany. Electronic address: philipp.bergschmidt@med.uni-rostock.de. 2. Department of Orthopaedics, University Medicine Rostock, Doberaner Strasse 142, Rostock 18057, Germany. 3. Department of Orthopaedics, Klinikum Neubrandenburg, Klosterberg 1a, Altentreptow 17087, Germany. 4. Department of Orthopaedics, University of Magdeburg, Leipziger Strasse 44, Magdeburg 39120, Germany. 5. Department of Orthopaedics, University Hamburg-Eppendorf, Martinistrasse 52, Hamburg 20246, Germany. 6. Istituti Ortopedici Rizzoli, 7 Divisione, Via Pupilli 1, Bologna 40136, Italy. 7. Hospital General Universitario de Elche, Camino de la Azara 11, Elche, Alicante, Spain. 8. Clinica Ortopedica e Traumatologica, Ospedale Sacro Cuore Don Calabria, Via Don A. Sempreboni 5, Negrar (VR) 37024, Italy. 9. Clinica Ortopedica e Traumatologica, Fondazione I.R.C.C.S. Policlinico San Matteo, Università di Pavia, V.le Golgi 19, Pavia 27100, Italy.
Abstract
BACKGROUND: Enhanced wear resistance of ceramics in general and improved mechanical characteristics of composite ceramics in terms of strength and resistance meet the demands for application in TKA. The aim of this prospective international multi-centre study was to evaluate the 5-year clinical and radiological outcomes of an unconstrained TKA with a composite ceramic femoral component. METHODS: A total of 107 patients (109 knees) underwent TKA with the MULTIGEN-PLUS Ceramic Knee at seven centres in three European countries. Clinical and radiological assessments were performed preoperatively and postoperatively at 3, 12, 24 and 60 months, using HSS, WOMAC, SF-36 and standardised radiographs. RESULTS: Mean HSS and WOMAC increased significantly from 55.1±11.5 (21-83) and 48.1±16.6 (3-90) preoperatively to 85.6±9.6 (49-98) and 73.3±20.4 (17-100) at 60 months. Mean SF-36 showed significant improvements in patients' quality of life (49.1±17.6 (12-96) preoperatively versus 67.7±23.1 (12-100) at 60 months). Non-progressive radiolucent lines (<1 mm) were observed around the femoral component in four cases. Neither implant migration nor loosening were registered. Kaplan-Meier survivorship was 96.0% at 60 months (92.1-100%, CI 95%). CONCLUSIONS: Five-year implant survival rate of the ceramic knee is comparable to other metallic and ceramic unconstrained TKA systems. Although the assessment of long-term implant survivorship is still pending, the ceramic implants represent a promising solution for patients with allergies against metallic components and furthermore for the general osteoarthritis population due to enhanced wear resistance.
BACKGROUND: Enhanced wear resistance of ceramics in general and improved mechanical characteristics of composite ceramics in terms of strength and resistance meet the demands for application in TKA. The aim of this prospective international multi-centre study was to evaluate the 5-year clinical and radiological outcomes of an unconstrained TKA with a composite ceramic femoral component. METHODS: A total of 107 patients (109 knees) underwent TKA with the MULTIGEN-PLUS Ceramic Knee at seven centres in three European countries. Clinical and radiological assessments were performed preoperatively and postoperatively at 3, 12, 24 and 60 months, using HSS, WOMAC, SF-36 and standardised radiographs. RESULTS: Mean HSS and WOMAC increased significantly from 55.1±11.5 (21-83) and 48.1±16.6 (3-90) preoperatively to 85.6±9.6 (49-98) and 73.3±20.4 (17-100) at 60 months. Mean SF-36 showed significant improvements in patients' quality of life (49.1±17.6 (12-96) preoperatively versus 67.7±23.1 (12-100) at 60 months). Non-progressive radiolucent lines (<1 mm) were observed around the femoral component in four cases. Neither implant migration nor loosening were registered. Kaplan-Meier survivorship was 96.0% at 60 months (92.1-100%, CI 95%). CONCLUSIONS: Five-year implant survival rate of the ceramic knee is comparable to other metallic and ceramic unconstrained TKA systems. Although the assessment of long-term implant survivorship is still pending, the ceramic implants represent a promising solution for patients with allergies against metallic components and furthermore for the general osteoarthritis population due to enhanced wear resistance.
Authors: Klemens Trieb; Andreas Artmann; Michael Krupa; Sasch Senck; Franz Landauer Journal: Medicine (Baltimore) Date: 2022-09-30 Impact factor: 1.817