title: Ceramic femoral components in total knee arthroplasty - two year follow-up results of an international prospective multi-centre study.
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.
authors.affiliation: Department of Orthopaedics, University of Rostock, Doberaner Strasse 142, 18057 Rostock, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Bergschmidt
authors.forename: Rainer
authors.initials: R
authors.lastname: Bader
authors.forename: Dirk
authors.initials: D
authors.lastname: Ganzer
authors.forename: Christian
authors.initials: C
authors.lastname: Hauzeur
authors.forename: Christoph
authors.initials: C
authors.lastname: Lohmann
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Rüther
authors.forename: Domenico
authors.initials: D
authors.lastname: Tigani
authors.forename: Nicola
authors.initials: N
authors.lastname: Rani
authors.forename: Fernando Lopez
authors.initials: FL
authors.lastname: Prats
authors.forename: Claudio
authors.initials: C
authors.lastname: Zorzi
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Madonna
authors.forename: Stefano
authors.initials: S
authors.lastname: Rigotti
authors.forename: Francesco
authors.initials: F
authors.lastname: Benazzo
authors.forename: Stefano Marco Paolo
authors.initials: SM
authors.lastname: Rossi
authors.forename: Guenther
authors.initials: G
authors.lastname: Kundt
authors.forename: Hans Rudolf
authors.initials: HR
authors.lastname: Bloch
authors.forename: Wolfram
authors.initials: W
authors.lastname: Mittelmeier