title: Prospective multi-centre study on a composite ceramic femoral component in total knee arthroplasty: Five-year clinical and radiological outcomes.
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.
authors: Department of Orthopaedics, University Medicine Rostock, Doberaner Strasse 142, Rostock 18057, Germany. Electronic address: philipp.bergschmidt@med.uni-rostock.de.
authors: Philipp
authors: P
authors: Bergschmidt
authors: Department of Orthopaedics, University Medicine Rostock, Doberaner Strasse 142, Rostock 18057, Germany.
authors: Rainer
authors: R
authors: Bader
authors: Department of Orthopaedics, Klinikum Neubrandenburg, Klosterberg 1a, Altentreptow 17087, Germany.
authors: Dirk
authors: D
authors: Ganzer
authors: Department of Orthopaedics, Klinikum Neubrandenburg, Klosterberg 1a, Altentreptow 17087, Germany.
authors: Christian
authors: C
authors: Hauzeur
authors: Department of Orthopaedics, University of Magdeburg, Leipziger Strasse 44, Magdeburg 39120, Germany.
authors: Christoph H
authors: CH
authors: Lohmann
authors: Department of Orthopaedics, University of Magdeburg, Leipziger Strasse 44, Magdeburg 39120, Germany.
authors: Alexander
authors: A
authors: Krüger
authors: Department of Orthopaedics, University Hamburg-Eppendorf, Martinistrasse 52, Hamburg 20246, Germany.
authors: Wolfgang
authors: W
authors: Rüther
authors: Istituti Ortopedici Rizzoli, 7 Divisione, Via Pupilli 1, Bologna 40136, Italy.
authors: Domenico
authors: D
authors: Tigani
authors: Istituti Ortopedici Rizzoli, 7 Divisione, Via Pupilli 1, Bologna 40136, Italy.
authors: Nicola
authors: N
authors: Rani
authors: Hospital General Universitario de Elche, Camino de la Azara 11, Elche, Alicante, Spain.
authors: José Luis
authors: JL
authors: Esteve
authors: Hospital General Universitario de Elche, Camino de la Azara 11, Elche, Alicante, Spain.
authors: Fernando Lopez
authors: FL
authors: Prats
authors: Clinica Ortopedica e Traumatologica, Ospedale Sacro Cuore Don Calabria, Via Don A. Sempreboni 5, Negrar (VR) 37024, Italy.
authors: Claudio
authors: C
authors: Zorzi
authors: Clinica Ortopedica e Traumatologica, Ospedale Sacro Cuore Don Calabria, Via Don A. Sempreboni 5, Negrar (VR) 37024, Italy.
authors: Vincenzo
authors: V
authors: Madonna
authors: Clinica Ortopedica e Traumatologica, Ospedale Sacro Cuore Don Calabria, Via Don A. Sempreboni 5, Negrar (VR) 37024, Italy.
authors: Stefano
authors: S
authors: Rigotti
authors: Clinica Ortopedica e Traumatologica, Fondazione I.R.C.C.S. Policlinico San Matteo, Università di Pavia, V.le Golgi 19, Pavia 27100, Italy.
authors: Francesco
authors: F
authors: Benazzo
authors: Clinica Ortopedica e Traumatologica, Fondazione I.R.C.C.S. Policlinico San Matteo, Università di Pavia, V.le Golgi 19, Pavia 27100, Italy.
authors: Stefano Marco Paolo
authors: SM
authors: Rossi
authors: Department of Orthopaedics, University Medicine Rostock, Doberaner Strasse 142, Rostock 18057, Germany.
authors: Wolfram
authors: W
authors: Mittelmeier
mesh_terms: D000368:Aged; D019645:Arthroplasty, Replacement, Knee / Q000379:methods*; D002516:Ceramics; D005260:Female; D005269:Femur / Q000000981:diagnostic imaging / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D007720:Knee Prosthesis; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000000981:diagnostic imaging* / Q000601:surgery*; D011184:Postoperative Period; D011446:Prospective Studies; D011474:Prosthesis Design; D011788:Quality of Life; D011859:Radiography; D013997:Time Factors; D016896:Treatment Outcome
keywords: Ceramics; Clinical outcome; Radiological outcome; Total knee arthroplasty