Page 220 - 《摩擦学学报》2021年第6期

第 6 期 杨抒, 等: 国内全髋关节置换磨损测试及数值模拟研究进展 1005

wear test and the computational simulation. Compared with other countries, the domestic pre-clinical wear study of hip
prosthesis is in the primary stage where there are very few articles on the above two approaches. Therefore, it is very
important to understand the basic research status of friction and wear of hip prosthesis in China. This article firstly
compared the kinematic and dynamic input of gait curves that are used in domestic hip wear assessments with the
Chinese measurement gait curves. Then this article summarized, compared and analyzed the results from both domestic
in-vitro simulator test and the computational simulation. And lastly this article discussed the limitations and future
development directions of the hip pre-clinical wear assessments. The main findings were: 1) The gait motion curves of
the Chinese were similar to the Western. The main difference lied in the gait joint force curves. And the Chinese
measurement curves cannot be directly used in hip wear evaluate tests as the measurement method of hip joint force
needs to be improved. 2) The domestic and the international research findings of in-vitro wear tests conducted according
to the ISO 14242-1 standard were similar but the results according to other testing standards (e.g., ISO 14242-3) showed
differences. This meant the accuracy of domestic in-vitro wear test results were influenced by the testing standards and
testing equipment. 3) The simplified dynamic curves according to the ISO 14242-1 can be input to the finite element
model to reduce the computational time. The wear rates of the domestic computational simulation were generally lower
than those of the in-vitro wear tests. As a result, the accuracy of domestic computational wear models needed further
improving. There were also some limitations on the current domestic wear assessments and researches. The first one was
the gap between the Chinese standards and international standards. Some extreme conditions like third body wear, edge
load and micro separation were not considered in current Chinese standards. Secondly there was still no gold standard on
extraction of wear debris. Thirdly it was difficult to consider simultaneously the factors from patients, doctors and
manufacturers that impacted on the wear performance of hip prosthesis. In order to catch up the international wear
research progress of hip prosthesis, the future domestic pre-clinical wear assessments should focus on: 1) Building the
national wear assessment standard that is appropriate for domestic patients; 2) Improving the extraction method of wear
debris; 3) Promoting the accuracy of computational model by adopting more realistic dynamics inputs and by optimizing
the wear models; 4) Combining the approaches of finite element analysis and force dependent kinematics to study the
impact of patients’ situations, doctor’s techniques, products parameters on the wear performance of hip prosthesis.
Key words: hip prosthesis; wear; in-vitro wear test; computational wear simulation; dynamic inputs of hip gait

髋关节是人体最大、最稳定的关节之一，如果髋 研究主要分为关节模拟机测试和计算机仿真研究. 髋
关节发生病变，会给病人带来诸多不适. 全髋关节置 关节模拟机通过模拟假体在体内的运动和受力情况，
换术可以治疗髋关节疾病、减轻患者病痛以及恢复关 实现对髋关节假体磨损的定量化评价. 我国2017年发

节功能. 根据瑞典关节置换登记系统(Swedish hip arthro- 布的《髋关节假体系统注册技术审查指导原则》中要
plasty register) 2019年的年报，磨损和磨损颗粒引起的 求新设计及使用新材料的髋关节假体应在临床前选
[1]
无菌性松动是导致手术翻修的主要原因，占比为56% . 取预期配合使用的最差型号规格，按照ISO系列标准
且临床结果表明，很大一部分患者会因为磨损和磨损 ISO 14242《外科植入物全髋关节假体的磨损》(国内等
导致的无菌性松动而进行二次手术 [2-3] . 因此人工髋关 同标准YY/T 0651)及ISO 17853《外科植入物材料的磨
节磨损和润滑机理的研究和髋关节假体及材料耐磨 损 聚乙烯和金属磨损颗粒的分离及表征》(国内等同
性能的评估，对延长假体的使用寿命至关重要. 标准YY/T 0652)进行磨损试验和耐磨性能评估 [4-5] . 但
国内外学者对髋关节假体磨损做了大量研究，根 是磨损试验流程复杂，设备昂贵，时间和测试成本都
据研究手段的不同，主要分为临床研究和体外研究. 很高，这种方法在国内还处于起步阶段，且设备数量
临床研究的方法有两种，其一是跟踪拍摄病人的X光 尚无法满足科学研究的需求. 另一种研究手段为计算
片，优点是能够真实反映假体在人体内的磨损情况， 机仿真，计算机磨损仿真的优点是可以作为磨损试验
但该方法只能评价穿透深度(线磨损率)，无法直接评 典型型号选择的辅助工具，同时节约时间和成本，便
价磨损体积，且测量精度较低；另一种临床研究的方 于参数化分析，为假体设计提供理论依据. 但是，计算
法为临床取出物体外磨损评估，或是对植入假体周围 机磨损仿真分析不能完全模拟髋关节假体在体内的
组织液中的磨屑进行提取研究，这种研究方式能够直 情况，仿真结果和实际结果存在一定差异.
接评估假体的磨损性能，反映临床使用情况，但存在 国外的髋关节磨损研究比国内起步早几十年，仿
样品数量有限和变量不可控等弊端. 假体磨损的体外 真和试验测试的方法都更为成熟，相关研究涵盖假体