First clinical study of a novel complete metal-free ceramic total knee replacement system

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.

Prospective Comparison of a Metal-Free Ceramic Total Knee Arthroplasty with an Identical Metal System

“…This is a prospective comparative study to clinically evaluate the Brehm-BKS-Integration knee arthroplasty system (Peter Brehm GmbH, Weisendorf, Germany). It is an open-label, prospective study, comparing results of a completely metal-free system using a composite matrix material containing aluminum oxide (Al 2 O 3 ) and zirconium oxide (ZrO 2 ) (Biolox Delta-CeramTec GmbH, Plochingen, Germany) to an anatomically identical metallic knee sys-tem made of a cobalt-chromium alloy (Co 28 Cr 6 Mo) produced by the same manufacturer [7,12]. This study received approval of the ethics committee of upper Austria including written consent of all patients (Study-Nr.…”

“…From total hip arthroplasty, it is known that ceramic implants display an appropriate component stability with low abrasive properties. Mayer et al recently published a 1-year shortterm study claiming that their first metal-free TKA with ceramic femoral and tibial components in conjunction with a polyethylene inlay provides a safe and efficient alternative [7].…”

“…The applied implant system has been introduced in a single-arm study by Mayer et al [7]. It is a non-constrained TKA with a bicondylar femoral and tibial component.…”

“…Patients fullfilling inclusion criteria were divided among two groups to either undergo implantation of a completely metal-free system using a composite matrix material containing aluminum oxide (Al 2 O 3 ) and zirconium oxide (ZrO 2 ) (ceramics group, n = 40, ▶ Fig. 1), or an anatomically identical metallic knee system made of a cobalt-chromium alloy (Co 28 Cr 6 Mo) (metal group, n = 40) produced by the same manufacturer [7,12]. Demographical data did not differ among the groups, except less male patients than females were in the ceramic group (▶ Table 1).…”

Interphalangeal arthrodesis using an intramedullary nitinol implant: a prospective study

“…To our knowledge, there is no similar metal-free system available on the market. As total hip and total knee replacement systems made of ceramic are currently being developed and optimized, [12,13] future efforts concerning metal-free intramedullary systems for interphalangeal arthrodesis might be necessary.…”