Abstract
Failure rates of 2–10% provide evidence for further development in knee arthroplasty. The purpose of our study was to examine the safety of the tibial component of a novel all-ceramic total knee replacement (TKR) (BPK-S Integration ceramic) consisting of BIOLOX®delta ceramic. The standards ISO 14879-1 and ASTM F1800-07 describe the test set-up for the experimental strength verification with a significantly increased maximum load of 5300 N (900 N are required) and post-fatigue burst strength testing. All specimens were able to prove their mechanical strength against fracture in the alternating load test. There was no material fracture in any of the included tibial components. The subsequent post-fatigue burst strength testing revealed the maximum strength against fracture of all specimens. With at least 9.7 kN for size 3 and at least 12.1 kN for size 6, all specimens showed relatively large strength reserves to the stress in the alternating load test. So far we simulated an in vivo lifetime of 10 years for the tibial component. Further studies should be conducted in which longer in vivo lifetimes of the components are simulated to investigate possible fatigue of the used material over a longer period of time.
Author contributions: K. Trieb designed and wrote the paper.
Author Statement
Research funding: Authors state no funding involved.
Conflict of interest: Authors state no conflict of interest.
Informed consent: Informed consent is not applicable.
Ethical approval: Ethical approval is not applicable.
References
[1] Abernethy PJ, Robinson CM, Fowler RM. Fracture of the metal tibial tray after Kinematic total knee replacement. A common cause of early aseptic failure. J Bone Joint Surg Br 1996; 78: 220–225.10.1302/0301-620X.78B2.0780220Search in Google Scholar PubMed
[2] ASTM Standard test method for cyclic fatigue testing of metal tibial tray components of total knee joint replacements (F1800-07). In: ASTM International, West Conshohocken, PA, USA, 2007: 2–3.Search in Google Scholar
[3] Berger C, Kloos K. Grundlagen der Werkstoff- und Bauteileigenschaften. In: Beitz W, Grote K-H, editors. Dubbel – Taschenbuch für den Maschinenbau. Heidelberg: Springer Verlag, 1997: E8.Search in Google Scholar
[4] Bergschmidt P, Bader R, Kluess D, et al. Total knee replacement system with a ceramic femoral component versus two traditional metallic designs: a prospective short-term study. J Orthop Surg (Hong Kong) 2013; 2: 294–299.10.1177/230949901302100306Search in Google Scholar
[5] 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: 871–876.10.1016/j.knee.2016.06.001Search in Google Scholar
[6] Caicedo MS, Pennekamp PH, McAllister K, Jacobs JJ, Hallab NJ. Soluble ions more than particulate cobalt-alloy implant debris induce monocyte costimulatory molecule expression and release of proinflammatory cytokines critical to metal-induced lymphocyte reactivity. J Biomed Mater Res A 2010; 93: 1312–1321.10.1002/jbm.a.32627Search in Google Scholar PubMed
[7] Carulli C, Villano M, Bucciarelli G, Martini C, Innocenti M. Painful knee arthroplasty: definition and overview. Clin Cases Miner Bone Metab 2011; 8: 23–25.Search in Google Scholar PubMed
[8] Dalla Pria P. Evolution and new application of the alumina ceramics in joint replacement. Eur J Orthop Surg Traumaol 2007; 17: 253–256.10.1007/s00590-006-0181-1Search in Google Scholar
[9] DIN EN ISO 21536:2009, Nichtaktive chirurgische Implantate – Implantate zum Gelenkersatz – Besondere Anforderungen an Implantate für den Kniegelenkersatz, Deutsche Fassung. In, Berlin, Germany, 2009: 7.Search in Google Scholar
[10] DIN ISO 14879-1:2000(E), Implants for surgery – Total knee-joint prostheses, Part 1: Determination of endurance properties of knee tibial trays. In: ISO copyright office CH-1211 Geneva 20, 2007: 4–5.Search in Google Scholar
[11] Feldhaus U. Finite-Elemente-Methode in der Motorenentwicklung. Motortechnische Zeitschrift 2008; 5: 428–431.10.1007/BF03227455Search in Google Scholar
[12] Gupta R, Phan D, Schwarzkopf R. Total knee arthroplasty failure induced by metal hypersensitivity. Am J Case Rep 2015; 16: 542–547.10.12659/AJCR.893609Search in Google Scholar PubMed
[13] Jacobs JJ, Hallab NJ. Loosening and osteolysis associated with metal-on-metal bearings: a local effect of metal hypersensitivity? J Bone Joint Surg Am 2006; 88: 1171–1172.10.2106/JBJS.F.00453Search in Google Scholar PubMed
[14] Kim KT, Lee S, Ko DO, Seo BS, Jung WS, Chang BK. Causes of failure after total knee arthroplasty in osteoarthritis patients 55 years of age or younger. Knee Surg Relat Res. 2014; 26: 13–19.10.5792/ksrr.2014.26.1.13Search in Google Scholar PubMed
[15] Kluess D, Schultze C, Lubomierski A, Mittelmeier W, Schmitz K-P, Bader R. Finite-element-analysis of a cemented ceramic knee arthroplasty under worst case scenarios. J Biomech 2008; 41: S237.10.1016/S0021-9290(08)70236-7Search in Google Scholar
[16] Majima T, Yasuda K, Tago H, Aoki Y, Minami A. Clinical results of posterior cruciate ligament retaining TKA with alumina ceramic condylar prosthesis: comparison to Co-Cr alloy prosthesis. Knee Surg Sports Traumatol Arthrosc 2008; 16: 152–156.10.1007/s00167-007-0435-4Search in Google Scholar PubMed
[17] Meier E, Gelse K, Trieb K, Pachowsky M, Hennig FF, Mauerer A. First clinical study of a novel complete metal-free ceramic total knee replacement system. J Orthop Surg Res 2016; 11: 21.10.1186/s13018-016-0352-7Search in Google Scholar PubMed
[18] Metsovitis SR, Ploumis AL, Chantzidis PT, et al. Rotaglide total knee arthroplasty: a long-term follow-up study. J Bone Joint Surg Am 2011; 93: 878–884.10.2106/JBJS.I.01702Search in Google Scholar PubMed
[19] Morlock M, Schneider E, Bluhm A, et al. Duration and frequency of everyday activities in total hip patients. J Biomech 2001; 34: 873–881.10.1016/S0021-9290(01)00035-5Search in Google Scholar
[20] Nagel K, Bishop NE, Schlegel UJ, Püschel K, Morlock MM. The influence of cement morphology parameters on the strength of the cement-bone interface in tibial tray fixation. J Arthroplasty 2017; 32: 563–569.10.1016/j.arth.2016.08.013Search in Google Scholar PubMed
[21] Naudie DD, Ammeen DJ, Engh GA, Rorabeck CH. Wear and osteolysis around total knee arthroplasty. J Am Acad Orthop Surg 2007; 15: 53–64.10.5435/00124635-200701000-00006Search in Google Scholar PubMed
[22] Oonishi H, Ueno M, Kim SC, Oonishi H, Iwamoto M, Kyomoto M. Ceramic versus cobalt-chrome femoral components; wear of polyethylene insert in total knee prosthesis. J Arthroplasty 2009; 24: 374–382.10.1016/j.arth.2007.10.021Search in Google Scholar PubMed
[23] Schlegel UJ, Bishop NE, Püschel K, Morlock MM, Nagel K. Comparison of different cement application techniques for tibial component fixation in TKA. Int Orthop 2015; 39: 47–54.10.1007/s00264-014-2468-xSearch in Google Scholar PubMed
[24] The Swedish Knee Arthroplasty Register: annual report. Department of Orthopedics, Lund University Hospital. Lund, Sweden: Wallin & Dalholm AB; 2012.Search in Google Scholar
©2018 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorial
- The role of textile engineering in regenerative medicine
- Research articles
- Fibrous composite material for textile heart valve design: in vitro assessment
- Electro-spun PLA-PEG-yarns for tissue engineering applications
- Preparation, characterization and blood compatibility assessment of a novel electrospun nanocomposite comprising polyurethane and ayurvedic-indhulekha oil for tissue engineering applications
- Three-dimensional bioglass-collagen-phosphatidylserine scaffolds designed with functionally graded structure and mechanical features
- Differential mineralization of human dental pulp stem cells on diverse polymers
- Heart valves from polyester fibers: a preliminary 6-month in vivo study
- Adaptation of cardiovascular system stent implants
- Synthesizing selenium- and silver-substituted hydroxyapatite-based bone grafts and their effects on antibacterial efficiency and cell viability
- Long-term recording performance and biocompatibility of chronically implanted cylindrically-shaped, polymer-based neural interfaces
- Morphology and contractile gene expression of adipose-derived mesenchymal stem cells in response to short-term cyclic uniaxial strain and TGF-β1
- A novel ceramic tibial component is as safe as its metal counterpart
- Short communication
- Hybrid textile heart valve prosthesis: preliminary in vitro evaluation
Articles in the same Issue
- Frontmatter
- Editorial
- The role of textile engineering in regenerative medicine
- Research articles
- Fibrous composite material for textile heart valve design: in vitro assessment
- Electro-spun PLA-PEG-yarns for tissue engineering applications
- Preparation, characterization and blood compatibility assessment of a novel electrospun nanocomposite comprising polyurethane and ayurvedic-indhulekha oil for tissue engineering applications
- Three-dimensional bioglass-collagen-phosphatidylserine scaffolds designed with functionally graded structure and mechanical features
- Differential mineralization of human dental pulp stem cells on diverse polymers
- Heart valves from polyester fibers: a preliminary 6-month in vivo study
- Adaptation of cardiovascular system stent implants
- Synthesizing selenium- and silver-substituted hydroxyapatite-based bone grafts and their effects on antibacterial efficiency and cell viability
- Long-term recording performance and biocompatibility of chronically implanted cylindrically-shaped, polymer-based neural interfaces
- Morphology and contractile gene expression of adipose-derived mesenchymal stem cells in response to short-term cyclic uniaxial strain and TGF-β1
- A novel ceramic tibial component is as safe as its metal counterpart
- Short communication
- Hybrid textile heart valve prosthesis: preliminary in vitro evaluation