First clinical study of a novel complete metal-free ceramic total knee replacement system
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RESEARCH ARTICLE
Open Access
First clinical study of a novel complete metal-free ceramic total knee replacement system E. Meier1*, K. Gelse1, K. Trieb2, M. Pachowsky1, F. F. Hennig1 and A. Mauerer1
Abstract Background: The aim of the study was to evaluate the safety and efficacy of a novel metal-free ceramic total knee replacement system. Methods: Thirty-eight primary total knee arthroplasties (TKAs) were performed on 34 patients using the metal-free BPK-S ceramic total knee replacement system with both the femoral and tibial components of an alumina/zirconia ceramic composite. The clinical outcome was evaluated pre- and postoperatively at 3 (n = 32 TKA) and 12 months (n = 32 TKA) using the Knee Society Score (KSS), the Oxford Knee Score and the EQ-5D. Safety analysis was performed by radiological examination and assessment of adverse events. Results: Postoperatively, the KSS, Oxford Knee Score and EQ-5D improved significantly at 3 and 12 months (p < 0.001). Non-progressive partial radiolucent lines were observed in six cases, but there was no osteolysis and no implant loosening. Induction or exacerbation of allergies did not occur during the follow-up. Conclusions: The metal-free BPK-S ceramic total knee replacement system proved to be a safe and clinically efficient alternative to metal implants in this short-term follow-up study. Keywords: Arthroplasty, Knee, TKA, Ceramic, Hypersensitivity
Background One major factor limiting the implant survival in total knee arthroplasty (TKA) is aseptic loosening due to immune reactions resulting from the agglomeration of debris as a result of wear [1–3]. In order to reduce the amount of implant wear, bearing couples of different materials have been investigated for decades. Due to favourable tribological properties, a significant reduction in wear rates of ceramic bearings has been well demonstrated in vitro and in vivo [4–6]. Furthermore, the release of wear particles may also elicit allergenic reactions, which are observed with metal implants [7]. Indeed, the prevalence of metal hypersensitivity is approximately 10–15 %, with nickel sensitivity having the highest prevalence in the presence of a common crossreactivity between nickel and cobalt [8]. Elevated cobalt * Correspondence: [email protected] 1 Department of Orthopaedic and Trauma Surgery, University Hospital Erlangen, Krankenhausstr. 12, 91054 Erlangen, Germany Full list of author information is available at the end of the article
and chromium serum ion levels were reported in patients after implantation of hip replacement devices [9]. Immunological metallic-specific responses to metal ions and metal debris are considered possible causes for postoperative pain, poor performance, osteolysis and early implant loosening [10, 11]. These data underline the rationale for an implant that is completely free from metal components. However, the brittleness and low tensile strength with the risk of material fractures are considerable problems for the use of ceramics in joint replacement. This is particularly true f
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