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骨科创新材料:交联聚乙烯(XPE)

[Innovative materials in orthopaedics: the crosslinked polyethylene (XPE)].

作者信息

Torre M, del Prever E Brach, Costa L, Romanini E, Masciocchi M, Manno V

机构信息

Istituto Superiore di Sanità, Centro Nazionale di Epidemiologia Sorveglianza e Promozione della Salute, Roma.

出版信息

Ann Ig. 2011 Jan-Feb;23(1):81-90.

Abstract

More than 150.000 hip and knee arthroplasties are performed every year in Italy. More than 50% of the patients receive a polyethylene component (Ultra High Molecular Weight PolyEthylene, UHMWPE). Polyethylene abrasive wear induces over time in vivo a foreign-body response and consequently osteolysis, pain and need of implant revision. Furthermore, oxidative wear due to gamma-rays sterilization caused in the '90ies several and severe failures. To solve these problems, since then, the orthopaedics research has been addressed to: 1) develop new cross linked polyethylene with a higher molecular mass than UHMWPE and, consequently, a higher abrasive wear resistance; 2) avoid the oxidative wear induced by gamma-rays sterilization, by using other sterilization methods and by stabilizing UHMWPE by means of antioxidants such as Vitamin E. According to the most recent studies, performed on limited cohorts and mostly funded by manufacturers, cross linked polyethylene shows a better abrasive wear resistance if compared to the conventional polyethylene but no significant differences have been detected in the clinical outcomes. Clinical follow up of Vitamin E stabilized PE are not yet available. The organization of national arthroplasties registries, able to trace and characterize the implanted devices and based on the whole patients population, will facilitate the early detection of devices that show a performance inferior than the expected one. In Italy, the National Institute of Health has been entrusted by the Ministry of Health to organize the national arthroplasty registry.

摘要

在意大利,每年进行超过15万例髋关节和膝关节置换手术。超过50%的患者接受聚乙烯部件(超高分子量聚乙烯,UHMWPE)。随着时间的推移,聚乙烯磨损会在体内引发异物反应,进而导致骨溶解、疼痛以及植入物翻修的需求。此外,20世纪90年代,伽马射线灭菌导致的氧化磨损引发了多起严重故障。为了解决这些问题,从那时起,骨科研究致力于:1)开发分子量高于UHMWPE且因此具有更高耐磨性能的新型交联聚乙烯;2)通过使用其他灭菌方法以及借助维生素E等抗氧化剂稳定UHMWPE,避免伽马射线灭菌引发的氧化磨损。根据对有限队列进行的、且大多由制造商资助的最新研究,与传统聚乙烯相比,交联聚乙烯显示出更好的耐磨性能,但在临床结果方面未检测到显著差异。维生素E稳定化聚乙烯的临床随访情况尚不可知。能够追踪并描述植入器械特征、基于全体患者人群的国家关节置换登记系统,将有助于早期发现性能低于预期的器械。在意大利,卫生部已委托国家卫生研究院组织国家关节置换登记系统。

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