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Femoral Stem Modularity: A Structural Fatigue Characterization

机译：股骨干模块化：结构性疲劳特性

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Femoral head modularity in total hip arthroplasty design emerged in the 1970s as an alternative to monolithic stem designs. Through the use of tapers, it has evolved to include the femoral neck and stem to provide off-the-shelf flexibility for accommodating difficult situations of femoral deformity and bone loss in both primary and revision situations. Although modular femoral stem designs have been successfully employed, they are not without clinical concerns, including structural compromise at taper interconnections because of cyclic microdisplacements. The ongoing laboratory-based structural fatigue characterization methodology presented in this paper was developed for the evaluation of composite materials, modular femoral stem designs, and systems incorporating proximal support. Specifically, a single, contemporary modular, proximally supported design that utilizes a solid femoral stem with a metaphyseal sleeve is employed. Three assemblies (baseline, alternate forging process, and lateralized neck) of the S-ROM Modular Hip System (DePuy Synthes, Warsaw, IN/Joint Medical Products, Stamford, CT) were evaluated under dynamic loading conditions and the number of cycles and peak loads plotted on a semilog scale to create a structural fatigue curve for each. The resulting endurance limits were 545 kgf, 622 kgf, and 454 kgf, respectively, with safety factors of 2.1 for the alternate forging process and 1.5 for the lateralized neck design. All of the stem failures across the three designs occurred slightly proximal to the distal end of the sleeve, within the sleeve-stem taper, and initiated across a lateral fretting surface. Although the examples presented are system specific, they demonstrate that the structural fatigue curve methodology can easily determine the influence of manufacturing and design variations once a baseline curve is established. This method has been employed continuously to determine the structural performance characteristics of other total hip systems since implementation. It suggests a proposed expansion of ASTM F2580-13 by providing testing parameters for researchers, medical device manufacturers, and regulatory agencies who are tasked with ensuring the safety and efficacy of total hip arthroplasty designs.
机译：1970年代，全髋关节置换术设计中的股骨头模块化技术成为整体式股骨柄设计的替代方案。通过使用锥度，它已经发展到包括股骨颈和股骨，以提供现成的灵活性，以适应在原发和翻修情况下股骨畸形和骨丢失的困难情况。尽管模块化的股骨柄设计已被成功采用，但它们并非没有临床问题，包括由于循环微位移而在锥度互连处的结构折衷。本文中介绍的正在进行的基于实验室的结构疲劳表征方法学，用于评估复合材料，股骨柄的模块化设计以及包含近端支撑的系统。具体地，采用了单一的，现代的，模块化的，近端支撑的设计，该设计利用了具有干phy端套筒的坚固的股骨柄。在动态载荷条件下评估了S-ROM模块化髋关节系统（DePuy Synthes，华沙，IN / Joint Medical Products，斯坦福德，康涅狄格州）的三个组件（基线，交替锻造过程和颈部偏侧）。以半对数比例绘制载荷，以为每个载荷创建结构疲劳曲线。最终的耐力极限分别为545 kgf，622 kgf和454 kgf，交替锻造工艺的安全系数为2.1，而颈部横向设计的安全系数为1.5。三种设计中的所有茎破坏都发生在套筒远端稍稍靠近套筒远端的位置，并在套筒杆锥度内发生，并在横向微动表面上引发。尽管给出的示例是系统特定的，但它们证明了一旦建立基线曲线，结构疲劳曲线方法就可以轻松确定制造和设计变化的影响。自实施以来，已连续采用此方法来确定其他全髋关节系统的结构性能特征。它建议为研究人员，医疗设备制造商和监管机构提供测试参数，以确保全髋关节置换设计的安全性和有效性，从而提出ASTM F2580-13的扩展建议。

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