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缩减恐慌——怎么会发生这种情况呢?

The taper disaster--how could it happen?

作者信息

Morlock Michael M

机构信息

Institute of Biomechanics, TUHH Hamburg University of Technology, Hamburg - Germany.

出版信息

Hip Int. 2015 Jul-Aug;25(4):339-46. doi: 10.5301/hipint.5000269. Epub 2015 May 20.

Abstract

Corrosion of metallic implants in contact with body fluids is unavoidable, especially at interfaces where movement occurs or in gaps. Corrosion became clinically relevant with the introduction of large modular metal-on-metal total hip joint articulations (MoM THA) early in the 21st century. This review attempts to summarise the scientific knowledge about taper problems available at the time of introduction of these bearings, why this "disaster" could happen. It is speculated that changes to the taper connection made in the 1990s to increase the range of motion with small heads (28 and 32 mm) reduced the mechanical strength of this connection, which did not matter for small heads. With the use of large and very large metal heads in MoM articulations, which have a larger lever arm and can generate high friction in unfavourable situations, suddenly the taper interface exhibited corrosion problems on a previously unknown scale. It is speculated that due to the higher mechanical loading with larger heads, the taper connection became less forgiving with respect to assembly conditions, contamination, manufacturing tolerances and other factors, which are yet not known. Since no major clinical problems had been reported before the introduction of these bearings and the pre-clinical testing was very successful, the disaster took its course. The patient-implant-surgeon system is a very complex intrinsically hazardous system. Pre-clinical testing addresses few and defined factors and such, good results cannot be directly transferred to the clinical reality. A controlled stepwise introduction of innovations is required.

摘要

金属植入物与体液接触时的腐蚀是不可避免的,尤其是在发生运动的界面处或间隙中。21世纪初,随着大型模块化金属对金属全髋关节置换术(MoM THA)的引入,腐蚀问题在临床上变得愈发重要。这篇综述试图总结在引入这些轴承时有关锥度问题的科学知识,以及为何会发生这种“灾难”。据推测,20世纪90年代为增加小头(28毫米和32毫米)的活动范围而对锥度连接所做的改变降低了该连接的机械强度,对于小头来说这并无大碍。随着在MoM关节置换中使用大型和超大型金属头,其具有更大的杠杆臂,并且在不利情况下会产生高摩擦力,突然间锥度界面出现了前所未有的腐蚀问题。据推测,由于较大金属头带来更高的机械负荷,锥度连接对于装配条件、污染、制造公差及其他未知因素的容忍度降低。由于在引入这些轴承之前未报告过重大临床问题,且临床前测试非常成功,这场灾难便接踵而至。患者 - 植入物 - 外科医生系统是一个极其复杂且本质上具有危险性的系统。临床前测试涉及的因素较少且明确,因此,良好的测试结果不能直接应用于临床实际。需要对创新进行可控的逐步引入。

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