BIOLOX® 陶瓷膝关节部件

在膝关节置换中采用BIOLOX®delta
非金属膝关节置换

人工膝关节置换的手术数量在逐年稳步增长。专家预测每年约有200万件膝关节假体被植入人体。膝关节置换继髋关节置换后成为非常常见的关节置换手术。

"现在全球整体人群的期望寿命比以前更高,对于膝关节置换后实现更高的生活质量和更好的活动能力的渴望在不断增加。而且,年轻活跃的患者行膝关节置换的比例也在提高。因此,膝关节置换必须能够提供更长的假体寿命。"

此外,感染、聚乙烯磨损、假体松动、金属过敏也是膝关节置换的最主要问题。无菌性松动是导致失败翻修的最常见原因(31.2%),其次是关节不稳(18.7%),感染(16.2%),聚乙烯磨损(10.0%)关节纤维化(6.9%)和力线不良(6.6%)1。这正是选择假体材料如此重要的原因,特别是在选择假体材料时要考虑到材料的抗磨损性能和生物学表现。

关节置换的感染 — 最常见的翻修原因之一2

显示更多

“假体周围感染(PJI)是关节置换中严重的并发症之一…假体周围感染的发生率呈现上升趋势, 在美国预计于2023年将有超过60000到70000例髋膝假体周围感染的病例” 3

随着髋膝关节翻修数量上升,在美国预计于2020年,用于感染翻修的花费将超过 16.2 亿美元 4。尽管假体周围感染不是常见的并发症(据报道美国发生率为1%-2%),但这是导致初次全膝关节置换翻修的第三大原因 27, 28

金属假体的问题: 磨损

显示更多

"膝关节假体通常采用钴铬钼合金制造;钛合金有时用来制造胫骨部件。由聚乙烯制成的垫片通常作为关节摩擦件与股骨部件配伍。临床实践证明,无菌性松动限制了人工膝关节假体的寿命。造成无菌性松动的一个重要原因是聚乙烯垫片的磨损7。"

正如许多研究所述,聚乙烯磨损率的增加会造成肉芽组织的形成、三体反应和骨质的破坏,导致松动率的提高。陶瓷材料可以减少聚乙烯磨损。

金属过敏

金属过敏

来源: CeramTec / Usbeck
 

来源: CeramTec / Usbeck
 

“假体功能良好的患者金属过敏的发生率是25%,大约是普通人群的2倍”。8

体内,金属离子的释放可引发生物学反应。制作金属假体所采用的合金中通常含有金属元素钴、铬和钼。许多研究报道金属过敏反应,例如湿疹、伤口愈合不良、反复渗液、局部肿胀、持续性疼痛、骨溶解、伴随着肌肉组织破坏的类假性肿瘤反应。8,9,16,17,18,19,20

许多金属过敏的患者最终翻修了膝关节假体。

BIOLOX®delta 陶瓷材料在膝关节置换术中具有优势 "

“在全膝关节置换中,经实验证实陶瓷材料具有优越的低磨损率,也显示其第一代临床应用结果同样令人鼓舞”。15

“陶瓷假体将为金属过敏的患者提供新的解决方案”。13

高性能陶瓷具有生物相容性和生物惰性10。陶瓷材料不引发过敏反应。许多髋膝关节置换的病例报告,采用陶瓷部件进行针对金属部件不良反应的翻修术后可以明显改善症状,并降低金属离子水平21,22,23,24,25,26

BIOLOX®陶瓷非常稳定、组织耐受良好11,12。目前已经应用于膝关节置换中13,14。超高的硬度和出色的表面光滑度是聚乙烯磨损降至最低15

研究结果表明陶瓷材料表现出最低的感染率5,29,30,31,32,33,34。这些研究比较研究了陶瓷、金属和聚乙烯。数据分析基于多家医院和登记中心的500749例髋关节翻修数据,采用Cox模型分析协同因素,证实了陶瓷具有降低感染翻修风险的潜能6

值得了解:

BIOLOX®delta — 非金属膝关节假体

  • 较低的感染翻修风险*
  • 在金属离子释放方面具有安全性*
  • 陶瓷颗粒不致引发病理反应*
  • 无已知的过敏风险*
  • 极佳的生物学表现*
  • 更低的聚乙烯磨损*
  • 抗三体磨损*
  • 超高抗刮擦关节面*
  • 5年成功的临床应用*

 
BIOLOX®delta膝关节假体由赛琅泰克的客户注册。尚未获FDA批准,并非在每个国家都能提供。
*相关文献可向赛琅泰克公司索取。

参考文献

  1. Lombardi AV Jr , Berend KR , Adams JB .: Why knee replacements fail in 2013: patient, surgeon, or implant?. Bone Joint J. 2014 Nov;96-B(11 Supple A):101-4. doi: 10.1302/0301-620X.96B11.34350
  2. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide:AOA; 2014
  3. A Recurring Slippery Slope, Javad Parvizi, M.D., F.R.C.S., CURRENT CONCEPTS IN JOINT REPLACEMENT® Winter 2014 Hyatt Regency Grand Cypress, Orlando, Florida, December 10 - 13, 2014
  4. Kurtz SM1, Lau E, Watson H, Schmier JK, Parvizi J., Economic burden of periprosthetic joint infection in the United States. J Arthroplasty. 2012 Sep;27(8 Suppl):61-5.e1. doi: 10.1016/j.arth.2012.02.022. Epub 2012 May 2.
  5. Liefheit K, Vergleichende Biofilmbildung auf Werkstoffe, Bericht, iba Heiligenstadt e.V. FB Biowerkstoffe, 2013
  6. Streicher R, Porporati A. News on ceramics – beyond wear reduction. Abstract EHS 2014, Streicher RLeto A., Pororati A.. News on ceramic – wear, corrosion and infection. Poster JHS 2014
  7. A. Seth Greenwald, DPhil(Oxon); Jonathan P. Garino, MD: Alternative Bearing Surfaces: The Good, the Bad, and the Ugly. J Bone Joint Surg Am, 2001 Nov; 83 (2 suppl 2): S68 -72 . http://dx.doi.org/
  8. Hallab NJ1, Anderson S, Stafford T, Glant T, Jacobs JJ.: Lymphocyte responses in patients with total hip arthroplasty. J Orthop Res. 2005 Mar;23(2):384-91.
  9. Gawkrodger DJ. Metal sensitivities and orthopaedic implants revisited: the potential for metal allergy with the new metal-on-metal joint prostheses. Br J Dermatol. 2003 Jun;148(6):1089-93.
  10. B. S. Bal, D. D. Greenberg, T. J. Aleto: Primary Total Knee Replacement with a Zirconia Ceramic Femoral Component. Bioceramics and Alternative Bearings in Joint Arthroplasty Ceramics in Orthopaedics2005, pp 183-190
  11. Hinorobu Oonishi M.D., PHD, S.-C. Kim, M. Kyomoto, M. Iwamoto, M. Ueno: Comparison of In-Vivo Wear between Polyethylene Inserts articulating against Ceramic and Cobalt-Chrome Femoral Components in Total Knee Prostheses. Bioceramics and Alternative Bearings in Joint Arthroplasty Ceramics in Orthopaedics2007, pp 149-159
  12. White SE, Whiteside LA, McCarthy DS, Anthony M, Poggie RA.: Simulated knee wear with cobalt chromium and oxidized zirconium knee femoral components. Clin Orthop Relat Res. 1994 Dec;(309):176-84.
  13. Philipp Bergschmidt, Rainer Bader, Dirk Ganzer, Christian Hauzeur, Christoph Lohmann, Alexander Krüger, Wolfgang Rüther, Domenico Tigani, Nicola Rani, José Luis Esteve, Fernando Lopez Prats, Claudio Zorzi, Vincenzo Madonna, Stefano Rigotti, Francesco Benazzo, Stefano Marco Paolo Rossi, Wolfram Mittelmeier: 15-year clinical and radiological outcomes of a prospective international multi-centre study on a ceramic femoral component in total knee arthroplasty. Deutscher Kongress für Orthopädie und Unfallchirurgie (DKOU 2014). Berlin, 28.-31.10.2014. Düsseldorf: German Medical Science GMS Publishing House; 2014. DocPO22-945
  14. Benazzo F, Dalla Pria P, Mittelmeier W, Tigani D, Zorzi C, Ganzer D, Lohmann CH, Cimbrelo EG, Merchan CR, Saura EM, Lizaur AU, Couceiro JF, Burelli S. Reasons using a Ceramic Femoral Component and First Clinical Experience. In:Chang JD, Billau K. (eds.).Bioceramics and Alternative Bearings in Joint Arthroplasty, Steinkopff-Verlag:145–148, 2007
  15. Zietz C, Bergschmidt P, Lange R, Mittelmeier W, Bader R. Third-body abrasive wear of tibial polyethylene inserts combined with metallic and ceramic femoral components in a knee simulator study. Int J Artif Organs 36(1):47-55, 2013
  16. Campbell P, Embrazadeh E, Nelson S et al. Histological features of pseudotumor-like tissues from metal-on-metal hips. Clin Orthop Relat Res 2010;468(9):2321-2327
  17. Kwon YM, Ostlere SJ, McLardy-Smith P et al. “Asymptomatic” pseudotumors after metal-on-metal hip resurfacing arthroplasty prevalence and metal ion study. J Arthroplasty 2010;92:356-361
  18. Malviya A, Holland JP. Pseudotumours associated with metal-on-metal hip resurfacing: 10-year Newcastle experience. Acta Orthop Belg 2009;75:477-483
  19. Registry AOANJRR, Demographics and Outcomes of Shoulder Arthroplasty, Report 2012
  20. Thomas P, Schuh A, Ring J, Thomsen M. [Orthopedic surgical implants and allergies. Joint statement by the Implant Allergy Working Group (AK 20) of the DGOOC (German Association of Orthopedics and Orthopedic Surgery), DKG (German Contact Dermatitis Research Group) and DGAKI (German Society for Allergology and Clinical Immunology], Orthopäde 2008; 37(1):75-88
  21. Algarni AD, Huk OL, Pelmus M. Metallosis-induced Iliopsoas Bursal Cyst Causing Venous Obstruction and Lower-limb Swelling After Metal-on-metal THA. Orthopedics 2012, 35(12):1066-1069
  22. 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
  23. Kosukegawa I, Nagoya S, Kaya M et al. Revision Total Hip Arthroplasty Due to Pain From Hypersensitivity to Cobalt-Chromium in Total Hip Arthroplasty. J Arthroplasty 2011;26(6):978.e1-3
  24. Krenn V, Thomas P, Thomsen M et al. Histopathological Particle Identification. CeraNews 2013:2:12-17
  25. Maurer-Ertl W, Friesenbichler J, Liegl-Atzwanger B et al. Noninflammatory Pseudotumor Simulating Venous Thrombosis After Metal-on-Metal Hip Resurfacing. Orthopedics 2011;34(10):678
  26. Watters TS, Cardona DM, Menon KS et al. Aseptic lymphocyte-dominated vasculitis-associated lesion: a clinicopathologic review of an underrecognized cause of prosthetic failure. Am J Clin Pathol 2010;134(6):886-93
  27. Kurtz SM, Ong KL, Lau E, Bozic KJ, Berry D, Parvizi J. Prosthetic joint infection risk after TKA in the Medicare population. Clin Orthop Relat Res 2010; 468:52-56.
  28. David J. Jaekel M.S., Ph.D., Kevin L. Ong Ph.D., P.E., Edmund C. Lau M.S., Steven M. Kurtz Ph.D.: The Epidemiology of Total Joint Arthroplasty Infections. Infected Total Joint Arthroplasty 2012, pp 35-54
  29. Trebse R, Levasic V, Milosevic I, Kovac S. Does the bearing type influence the incidence of periprosthetic infections of the hip? CeraNews 1/2014, 12-14
  30. Parvizi J. Periprosthetic joint infection: could the bearing surface play a role? CeraNews 1/2014, 11
  31. Smith L, Alijanipour P, Restrepo C, Maltenfort M, Parvizi J, Malkani A. Periprosthetic joint infection: could the bearing surface play a role? Abstract, Meeting of the Eastern Orthopaedic Association 2014
  32. 10th Annual Report: National Joint Registry for England, Wales and Northern Ireland, 2013
  33. Falcioni S, Ancarani C, Bordini B, Pichierri M, Stea S. Influence of articular coupling on septic loosening of total hip arthroplasty. Abstract EHS 2014
  34. Steven M. Kurtz PhD, Edmund Lau MS, Kevin Ong PhD, Ke Zhao MA, MS, Michael Kelly MD, Kevin J. Bozic MD, MBA: Future Young Patient Demand for Primary and Revision Joint Replacement. National Projections from 2010 to 2030. Clin Orthop Relat Res (2009) 467:2606–2612, DOI 10.1007/s11999-009-0834-6

推荐联系人

请点击“联络”按钮获取CeramTec集团中您要寻找的联络人或直接负责人的列表。