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Published on: May 14, 2020
First clinical study of a novel complete metal-free ceramic total knee replacement system
1Department of Orthopaedic and Trauma Surgery, University Hospital Erlangen, Krankenhausstr. 12, 91054, Erlangen, Germany. eva.meier@uk-erlangen.de.
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.

