Understanding the differences in wear testing method standards for total knee replacement.
Understanding the differences in wear testing method standards for total knee replacement.
复制标题
了解全膝关节置换术磨损测试方法标准的差异。
DOI：
10.1016/j.jmbbm.2022.105258
复制
发表时间：
2022
影响因子：
3.9
通讯作者：
Abdelgaied A
中科院分区：
文献类型：
--
作者：
Abdelgaied A
全膝关节置换术（TKR）磨损的临床前评价通常使用国际标准化组织（ISO）测试方法进行。已经制定了两个TKR临床前磨损模拟的国际标准;使用力或位移控制。此外，基于先前发表的健康受试者的测量运动学，利兹大学还开发了步态周期（位移控制），其早于ISO位移控制标准。此外，不同的试验方法采用不同的方法来确定旋转中心和运动的极性（作用方向）。然而，使用这些不同的控制制度和输入条件对任何一个TKR的运动学、接触力学和磨损的影响以前都没有得到充分的研究。当前的研究调查了在ISO力和位移控制测试方法以及利兹步态周期输入下跑步时TKR的运动学、接触力学和磨损性能，使用实验和计算模拟方法。目的是了解不同测试方法标准条件预测的机械和摩擦学结果。使用中等尺寸Sigma弯型TKR（DePuy，UK）和中度交联UHMWPE弯型内衬研究了三个ISO磨损试验标准：ISO-14243-3-2004、ISO-14243-3-2014和ISO-14243-1-2009。此外，还研究了利兹位移控制步态周期。根据计算模拟预测，与ISO-2004标准相比，位移控制ISO-2014标准中前后（AP）位移和胫骨旋转极性的逆转导致了超过65 MPa的高应力，该TKR设计的衬垫后缘磨损率增加超过10%。尽管利兹步态输入运动学导致股骨后滚，但不会导致衬垫后缘上的高应力边缘载荷。这归因于位移控制标准ISO-2014和利兹步态测试方法中采用的不同测试输入运动学和股骨部件的不同旋转中心。力控制ISO-2009预测的AP位移和胫骨旋转与相应的位移控制曲线具有不同的极性和幅度。此外，根据计算模型，在力控制ISO-2009标准下预测的磨损率是在位移控制ISO标准下预测的磨损率的两倍以上，因为在力控制标准下预测的AP位移和胫骨旋转运动增加。这些力学和磨损方面的主要差异，不同试验方法之间的差异意味着，每种标准品必须与来自具有已证实临床历史的器械的自身同品种对照品结果一起使用，并且不应比较不同标准品的结果，因为测试方法标准的选择很可能取决于膝关节的设计方案。临床上，人群中的运动学变化极大，导致磨损率高度可变。虽然标准方法是必要的，但其本身是不够的，需要在具有不同运动学条件、不同软组织约束以及不同对线的代表性条件组合下进行测试，以便确定临床预期磨损率的变异性和范围。这项研究使进一步的进展对这样一个组合的代表性条件的定义，通过加深理解的关系…
Preclinical evaluation of the wear of total knee replacements (TKR) is usually undertaken using International Standards Organization (ISO) test methods. Two international standards for the preclinical wear simulation of TKRs have been developed; using either force or displacement control. In addition, based on previously published measured kinematics of healthy subjects, a gait cycle (displacement control) was also developed at the University of Leeds, which pre-dates the ISO displacement control standard. Furthermore, different test methods have adopted different approaches to defining the centres of rotation and polarity (direction of application) of motions. However, the effects of using these different control regimes and input conditions on the kinematics, contact mechanics, and wear of any one TKR have not been fully investigated previously.The current study investigated the kinematics, contact mechanics, and wear performance of a TKR when running under ISO force and displacement control test methods as well as the Leeds gait cycle inputs using experimental and computational simulation methods, with the aim of understanding the mechanical and tribological outcomes predicted by the different test method standard conditions. Three ISO wear testing standards were investigated using a mid-size Sigma curved TKR (DePuy, UK), with moderately cross-linked UHMWPE curved inserts; ISO-14243-3-2004, ISO-14243-3-2014 and ISO-14243-1-2009. In addition, the Leeds displacement control gait cycle was also investigated.According to the computational simulation predictions, reversing the anterior-posterior (AP) displacement and tibial rotation polarities in the displacement control ISO-2014 standard compared to the ISO-2004 standard resulted in high stress, of more than 65 MPa, at the posterior edge of the inserts with more than 10% increase in wear rate for this TKR design. Although Leeds gait input kinematics produced femoral rollback, it did not result in high stress edge loading on the posterior lip of the insert. This was attributed to different test input kinematics and different centres of rotation of the femoral component adopted in the displacement control standard ISO-2014 and Leeds gait test methods. The predicted AP displacement and tibial rotation from the force control ISO-2009 had different polarities and magnitudes to the corresponding displacement control profiles. In addition, the predicted wear rate, from the computational model, under the force control ISO-2009 standard was more than double that predicted under displacement control ISO standards due to the increased AP displacement and tibial rotation motions predicted under the force control standard.These major differences, in the mechanics and wear, between different test methods imply that each standard must therefore be used with its own predicate control results from a device with proven clinical history and results across different standards should never be compared, as the choice of test method standard may well be dependent on the design solution for the knee. Clinically, the kinematics in the population are extremely variable, which results in highly variable wear rates. While a standard method is necessary, on its own it is not adequate and needs to be supported by tests under a portfolio of representative conditions with different kinematic conditions, different soft tissue constraints, as well as with different alignments, so that the variability and range of wear rates expected clinically might be determined. This study enables further progress towards the definition of such a portfolio of representative conditions, by deepening the understanding of the relationships …
登录
查看更多内容
在一系列活动期间，正常人和残疾人的髋关节和膝关节传递的力。
影响因子：
0.4
作者：
Paul Jp;McGrouther Da
通讯作者：
McGrouther Da
影响因子：
2.4
作者：
Abdelgaied, Abdellatif;Liu, Feng;Jin, Zhongmin
通讯作者：
Jin, Zhongmin
影响因子：
3.9
作者：
Schutz, Pascal;Postolka, Barbara;List, Renate
通讯作者：
List, Renate
DOI：
10.1098/rspb.1976.0004
发表时间：
1976-01-01
期刊：
PROCEEDINGS OF THE ROYAL SOCIETY SERIES B-BIOLOGICAL SCIENCES
影响因子：
--
作者：
PAUL, JP
通讯作者：
PAUL, JP