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评估模块化髋臼陶瓷内衬新型植入方法的可行性和可重复性。

Evaluating the Feasibility and Reproducibility of a Novel Insertion Method for Modular Acetabular Ceramic Liners.

作者信息

Hunger Sandra, Seidler Alexander, Rotsch Christian, Heyde Christoph-Eckhard, Drossel Welf-Guntram

机构信息

Fraunhofer Institute for Machine Tools and Forming Technology IWU, 01187 Dresden, Germany.

Department of Orthopaedic, Trauma and Plastic Surgery Clinic, University of Leipzig Medical Center, 04103 Leipzig, Germany.

出版信息

Bioengineering (Basel). 2023 Oct 11;10(10):1180. doi: 10.3390/bioengineering10101180.

Abstract

Modern hip implants have a modular design. In case of wear or other damage it allows surgeons to change the tribological partners, i.e., the acetabular liner and femoral ball. In both revision and primary surgery, the secure joining of the implant components is important for the success of the operation. The two components, namely the ceramic liner and hip cup, are connected via a conical press connection and should be concentrically aligned to avoid chipping. Malseated liners can reduce the life span in situ. The amount of the joining force, which is usually applied via a hammer, depends on the surgeon. In this study, an alternative joining method for acetabular ceramic liners in hip cups was investigated, which intends to make the process more reproducible and thus safer. For this purpose, a handpiece was used to apply a defined force impulse of 4 kN. For the concentric alignment of a ceramic liner in the hip cup, an adapter was developed based on findings via a qualitative finite element (FE) analysis. Insertion and pushout tests of the acetabular cup-liner connection were performed in the laboratory with the new instrument (handpiece with the connected adapter) to evaluate the functionality of the instrument and the reproducibility of the new insertion method. For comparison, liners and acetabular cups were joined using a testing machine according to the standard. The presented results demonstrate the technical proof-of-concept of the new joining method under laboratory conditions. They meet the acceptance criteria of established manufacturers, which proves the equivalency to proven methods for joining modular implant components. To verify the improvement of the new joining method compared to the conventionally used joining method, an application-oriented study with different surgeons and the new joining instrument under clinical conditions is necessary.

摘要

现代髋关节植入物采用模块化设计。在出现磨损或其他损坏的情况下,外科医生可以更换摩擦学配对部件,即髋臼内衬和股骨头。在翻修手术和初次手术中,植入物组件的牢固连接对于手术成功至关重要。这两个组件,即陶瓷内衬和髋臼杯,通过锥形压配合连接,并且应同心对齐以避免碎裂。内衬安装不当会缩短其在位使用寿命。连接力的大小通常通过锤子施加,这取决于外科医生。在本研究中,对髋臼陶瓷内衬在髋臼杯中的一种替代连接方法进行了研究,旨在使该过程更具可重复性,从而更安全。为此,使用了一个手持器械施加4 kN的规定力脉冲。为了使陶瓷内衬在髋臼杯中同心对齐,基于定性有限元分析的结果开发了一种适配器。在实验室中使用新器械(带有连接适配器的手持器械)对髋臼杯 - 内衬连接进行插入和推出测试,以评估器械的功能和新插入方法的可重复性。作为比较,根据标准使用测试机连接内衬和髋臼杯。给出的结果证明了新连接方法在实验室条件下的技术概念验证。它们符合知名制造商的验收标准,这证明了与用于连接模块化植入物组件的成熟方法等效。为了验证新连接方法相对于传统使用的连接方法的改进,有必要在临床条件下针对不同外科医生和新连接器械进行一项面向应用的研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/923e/10604853/3c1114692a1f/bioengineering-10-01180-g001.jpg

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