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Observational Study
. 2016 Feb 8:11:21.
doi: 10.1186/s13018-016-0352-7.

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

E Meier  1 , K Gelse  2 , K Trieb  3 , M Pachowsky  2 , F F Hennig  2 , A Mauerer  2
Affiliations
Observational Study

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

E Meier et al. J Orthop Surg Res. .

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.

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Figures

Fig. 1
Fig. 1
BPK-S Integration total knee replacement system with femoral and tibial component of Biolox® ceramic composite (Peter Brehm, Germany)
Fig. 2
Fig. 2
Size specifications of the femoral component of the BPK-S Integration total knee replacement system
Fig. 3
Fig. 3
Size specifications of the tibial component of the BPK-S Integration total knee replacement system
Fig. 4
Fig. 4
Boxplot analysis of the KSS score values (functional score and knee score preoperatively as well as at 3 and 12 months postoperatively (**p < 0.01 vs. preoperative)
Fig. 5
Fig. 5
Boxplot analysis of the Oxford Knee Score preoperatively as well as at 3 and 12 months postoperatively (**p < 0.01 vs. preoperative)
Fig. 6
Fig. 6
Boxplot analysis of the EQ-5D score values preoperatively as well as at 3 and 12 months postoperatively (**p < 0.01 vs. preoperative)
Fig. 7
Fig. 7
Radiographs of one patient preoperatively (a), postoperatively (day of surgery) (b), 3 months (c) and 12 months (d) after surgery
See this image and copyright information in PMC

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