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

Abstract

Aims The aim of this open-label, prospective, short-term study was to carry out an initial comparison of a completely metal-free ceramic with a geometrically identical metallic arthroplasty over a 1-year follow-up period.

Methods This study investigates a completely metal-free system using a composite matrix material containing aluminum oxide (Al₂O₃, BPK-S Integration, Peter Brehm GmbH, Weisendorf, Germany) or zirconium oxide (ZrO₂, BPK-S Integration Ceramic, Biolox Delta-CeramTec GmbH, Plochingen, Germany). Eighty patients (40 in each group) received either a completely metal-free ceramic system (matrix of aluminum and zirconium oxide) or an anatomically identical metallic knee system made of a cobalt-chromium alloy. Clinical assessment was performed preoperatively, and during follow-up at 3 and 12 months, using the Knee Society Score, Oxford Knee Score, and EQ-5D-VAS. For radiological evaluation, standard preoperative and postoperative standardized radiographs were taken at the given follow-up visits.

Results The postoperative clinical scores improved significantly at the 3- and 12-month follow-ups, but did not differ statistically between the two groups. The radiologically evaluated mean postoperative mechanical and anatomical axes showed proper alignment within both groups at all times. No revision surgery had to be performed, and no complications or loosening were recorded whatsoever.

Conclusions To our knowledge, this is the first study comparing a total ceramic metal-free knee system with a geometrically identical metallic TKA (total knee arthroplasty). Longer follow-ups will be required to demonstrate the overall efficiency of this TKR and perhaps to expand its medical indication.

Zusammenfassung

Einleitung Das Ziel dieser offenen prospektiven Kurzzeitstudie war der initiale Vergleich einer komplett metallfreien Keramik-Knietotalendoprothese mit einer geometrisch identischen metallischen Variante über eine 1-Jahres-Nachuntersuchungsperiode.

Methode Verglichen wurden zwei geometrisch gleiche Kniesysteme bestehend entweder aus einer metallischen CoCr-Legierung oder Keramik (Al₂O₃ bzw. ZrO₂, BPK-S Integration, Peter Brehm GmbH, Weisendorf, Deutschland) oder Zirkoniumoxid (BPK-S Integration Ceramic, ZrO₂, Biolox Delta-ceramic). 80 Patienten (40 in jeder Gruppe) erhielten entweder ein komplett metallfreies Keramiksystem (Gemisch aus Aluminium und Zirkoniumoxid) oder eine anatomisch identische metallische Variante, hergestellt aus Kobalt und Chrom. Die klinische Erhebung wurde präoperativ und bei Verlaufskontrollen nach 3 und 12 Monaten durchgeführt, unter Verwendung des Knee Society Score, Oxford Knee Score und EQ-5D-VAS. Zur radiologischen Untersuchung wurden standardisierte prä- und postoperative Röntgenbilder zu dem jeweiligen Zeitpunkt durchgeführt.

Ergebnisse Die postoperativen klinischen Untersuchungsergebnisse haben sich im Vergleich zum präoperativen Score nach 3 und 12 Monaten signifikant verbessert, zeigten jedoch keinen Unterschied zwischen den beiden Systemen. Die radiologische Untersuchung zeigte eine signifikante Verbesserung der anatomischen und mechanischen Achse. Zu keinem Zeitpunkt wurde eine Revisionsoperation durchgeführt. Es zeigten sich keine operativen Komplikationen und keine Lockerungen.

Diskussion Dies ist nach unserem Wissen die erste Studie, die einen totalen Knieersatz aus Keramik mit einem geometrisch identen Metallknie vergleicht. Längere Nachuntersuchungszeiträume dieses Keramiksystems werden die Indikation eventuell erweitern.

Key words

knee - arthroplasty - ceramic

Schlüsselwörter

Knie - Endoprothese - Keramik

• References

• 1 Lee GC. Whatʼs new in adult reconstructive knee surgery. J Bone Joint Surg Am 2016; 98: 156-165
• 2 Willmann G. 20 years aluminum oxide ceramics for medical applications (German). Biomed Tech (Berl) 1994; 39: 73-78
• 3 Kretzer JP, Reinders J, Sonntag R. et al. Wear in total knee arthroplasty – just a question of polyethylene? Metal ion release in total knee arthroplasty. Int Orthop 2014; 38: 335-340
• 4 Lombardi Jr. AV, Berend KR, Adams JB. Why knee replacements fail in 2013: patient, surgeon, or implant?. Bone Joint J 2014; 96: 101-104
• 5 Gupta R, Phan D, Schwarzkopf R. Total knee arthroplasty failure induced by metal hypersensitivity. Am J Case Rep 2015; 16: 542-547
• 6 Middleton S, Toms A. Allergy in total knee arthroplasty: a review of the facts. Bone Joint J 2016; 98: 437-441
• 7 Meier E, Gelse K, Trieb K. et al. First clinical study of a novel complete metal-free ceramic total knee replacement system. J Orthop Surg Res 2016; 11: 21-27
• 8 Bergschmidt P, Ellenrieder M, Bader R. et al. Prospective comparative clinical study of ceramic and metallic femoral components for total knee arthroplasty over a five-year follow-up period. Knee 2016; 23: 871-876
• 9 Bergschmidt P, Dammer R, Zietz C. et al. Adhesive strength of total knee endoprostheses to bone cement – analysis of metallic and ceramic femoral components under worst-case conditions. Biomed Tech (Berl) 2016; 61: 281-289
• 10 Laskin RS. An oxidized Zr ceramic surfaced femoral component for total knee arthroplasty. Clin Orthop Relat Res 2003; 416: 191-196
• 11 Bal BS, Greenberg DD, Buhrmester L, Aleto TJ. Primary TKA with a zirconia ceramic femoral component. J Knee Surg 2006; 19: 89-93
• 12 Muenzberg M, Stretz C, Baur W. et al. Gender influence on the outcome of an unisex total knee arthroplasty system. Technol Health Care 2014; 22: 129-136
• 13 Oonishi H, Ueno M, Kim SC. et al. Ceramic versus cobalt-chrome femoral components; wear of polyethylene insert in total knee prosthesis. J Arthroplasty 2009; 24: 374-382
• 14 Bergschmidt P, Bader R, Mittelmeier W. Metal hypersensitivity in total knee arthroplasty: revision surgery using a ceramic femoral component – a case report. Knee 2012; 19: 144-147
• 15 Bergschmidt P, Bader R, Ganzer D. et al. Ceramic femoral components in total knee arthroplasty – two year follow-up results of an international prospective multi-centre study. Open Orthop J 2012; 6: 172-178
• 16 Yasuda K, Miyagi N, Kaneda K. Low friction total knee arthroplasty with the alumina ceramic condylar prosthesis. Bull Hosp Jt Dis 1993; 53: 15-21
• 17 Tateishi H, Maruoka T, Yoh K. et al. A long-term follow-up study of unicompartmental replacement with a Marmor knee prosthesis and the introduction of a new ceramic prosthesis. Bull Hosp Jt Dis Orthop Inst 1991; 51: 132-139
• 18 Nieuwenhuijse MJ, Nelissen RG, Schoones JW, Sedrakyan A. Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies. BMJ 2014; 349: g5133
• 19 Jeon YS, Shin JS, Jung JH, Kim MK. Total knee arthroplasty using NexGen LPS-flex^® improves clinical outcomes without early loosening: minimum 6-year follow-up results. J Orthop Surg Res 2016; 11: 83-87
• 20 Marx R, Faramarzi R, Oberbach T. et al. PVD-silicoating before cementation of zirconia-based knee prostheses effects better cement adhesion and lower aseptic loosening rates. Z Orthop Unfall 2012; 150: 40-47
• 21 Cristofolini L, Affatato S, Erani P. et al. Implant fixation in knee replacement: preliminary in vitro comparison of ceramic and metal cemented femoral components. Knee 2009; 16: 101-108
• 22 Marx B, Marx R, Reisgen U, Wirtz D. Bone cement adhesion on ceramic surfaces – surface activation of retention surfaces of knee prostheses by atmospheric plasma versus thermal surface treatment. Z Orthop Unfall 2015; 153: 146-152
• 23 Kumahashi N, Uchio Y, Kitamura N. et al. Biomechanical comparison of the strength of adhesion of polymethylmethacrylate cement to zirconia ceramic and cobalt-chromium alloy components in a total knee arthroplasty. J Orthop Sci 2014; 19: 940-947
• 24 Trieb K. A novel ceramic tibial component is as safe as its metal counterpart. Biomed Tech (Berl) 03.08.2017; [Epub ahead of print]