Abstract
BackgroundThe aim of the study was to evaluate the safety and efficacy of a novel metal-free ceramic total knee replacement system.MethodsThirty-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.ResultsPostoperatively, 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.ConclusionsThe 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.
Highlights
The aim of the study was to evaluate the safety and efficacy of a novel metal-free ceramic total knee replacement system
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 [1,2,3]
A total of 34 patients were enrolled in the study (n = 38 TKA)
Summary
The aim of the study was to evaluate the safety and efficacy of a novel metal-free ceramic total knee replacement system. 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 [1,2,3]. 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 [4,5,6]. The release of wear particles may elicit allergenic reactions, which are observed with metal implants [7].
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