人工关节假体磨屑提取分离、表征和识别的研究进展
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1.国家药品监督管理局医疗器械技术审评检查大湾区分中心;2.西南交通大学;3.国家药品监督管理局医疗器械技术审评中心;4.上海大学

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Research Progress on Extraction and Isolation, Characterization and Identification of Wear Debris for Artificial Joints
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1.GBA Center for Medical Device Evaluation and Inspection;2.Tribology Research Institute, School of Mechanical Engineering, Southwest Jiaotong University;3.Center for Medical Device Evaluation;4.Shanghai University

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    摘要:

    人工关节假体服役过程中产生的磨屑,会与骨组织发生反应并诱导骨溶解,严重影响人工关节假体的使用寿命。本文通过检索、总结、归纳和分析国内外不同人工关节材料磨屑的提取、表征以及识别的相关研究文献,以期为日后构建系统性、层次性的人工关节磨屑研究体系提供参考和可行思路。本文的主要发现为:1)强碱法、强酸法、蛋白酶法是目前提取人工关节磨屑的常用方法,研究人员明确了这三种磨屑提取方法的蛋白降解机制。2)体内外的磨屑表征多为髋、膝关节,少量涉及颈椎、脚踝关节,研究表明磨损颗粒的大小、数量、形状和体积受关节类型、接触区域、材料选择、植入时间等因素的影响。国内外均进行了体外模拟测试后磨屑的表征研究,但国内仍缺少临床取出物的磨屑表征分析。3)当前研究多为传统机械领域的磨屑识别,针对人工关节磨屑的智能识别研究较少,说明计算机技术在人工关节磨屑识别领域的应用存在一定的滞后性。

    Abstract:

    The wear debris generated during artificial joint prosthesis service can react with bone tissue to form osteolysis, seriously affecting the life-time of artificial joint prostheses. This paper reviews, summarizes, and analyzes domestic and international research literature on the extraction, characterization, and identification of wear debris from different artificial joint materials, aiming to provide references and feasible ideas for the future construction of a systematic and hierarchical research system for artificial joint wear debris. The main findings of this paper are: 1) Strong alkali protein degradation test, strong acid protein degradation test, and protease protein degradation test are the commonly used methods for extracting artificial joint wear debris, and researchers have clarified the protein degradation mechanisms of these three debris extraction methods. 2) The characterization of wear debris in-vitro and in-vivo is mostly for hip and knee joints, with a small amount involving cervical spine and ankle joints. Studies have shown that the size, quantity, shape, and volume of wear particles are influenced by factors such as joint type, contact area, material selection, and implantation time. Both domestic and international studies have conducted characterization research on wear debris after in-vitro simulation testing, but there is still a lack of wear debris characterization analysis of clinical retrievals in China. 3) Currently, most research is on the recognition of wear debris in the traditional mechanical field, but there is little research on the intelligent recognition of artificial joint wear debris, indicating that there is a certain lag in the application of computer technology in the field of artificial joint wear debris recognition.

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  • 收稿日期:2024-12-18
  • 最后修改日期:2025-01-19
  • 录用日期:2025-01-20
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