1.1 本实践为测量股骨头和髋臼组件的相对位移提供了指导，这些位移是由全髋关节置换术关节界面处发生的磨损和变形引起的，这些磨损和变形来自连续的临床X线照片。 1.2 该实践主要用于评估接受由聚乙烯髋臼组件与金属或陶瓷股骨头铰接组成的THR的患者。 1.3 所谓的硬对硬关节，如金属对金属和陶瓷对陶瓷THR，并不打算直接解决。 1.4 这种做法将侧重于测量相对位移随时间变化的计算机辅助计算方法，但并不排除其他方法。 1.5 本规程描述了利用各种计算方法进行射线照相磨损/蠕变研究的方法，并不旨在推广或认可特定方法。 1.6 本实践的目的不是提供各种计算方法使用的详细说明，这些说明包含在相应的用户手册中。 1.7 本规程旨在比较接受不同配方轴承材料的患者组中发生的相对位移。然而，必须认识到 体内 条件。单一的临床研究可能不具有普遍代表性。 1.8 这种做法不是一种性能标准。本实践的使用者有责任描述所评估假体的安全性和有效性。 1.9 以国际单位制表示的值应被视为标准，但角度测量除外，角度测量可以以度或弧度报告。此外，像素密度也可以英制单位报告。 1.10 本标准的使用可能涉及潜在危险的射线照相设备的操作，并不旨在解决与射线照相相关的安全预防措施。本标准的使用者有责任定义和建立适当的安全实践。 在操作射线照相设备之前，该标准没有确定监管限制的适用性。 1.11 本标准并不旨在解决与其使用相关的所有安全问题（如果有的话）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.12 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 =====意义和用途====== 4.1 本实践使用接受全髋关节置换术的患者髋关节的临床X线照片来测量关节界面塑性变形和磨损的综合影响，这导致三个- 股骨头进入髋臼组件的尺寸位移。 4.2 本实践旨在验证可用于测量THR关节面蠕变/磨损程度的各种计算方法。 4.3 本规程涉及分析所需的射线照相投影类型以及获得高质量胶片所需的一般射线照相参数。 4.4 本规程规定了评估临床放射线照片以纳入研究的标准。 4.5 这种做法解决了将射线照相图像转换为各种计算机辅助计算方法所需的适当数字格式的问题。

1.1 This practice provides guidance for the measurement of the relative displacement of the femoral head and acetabular component that results from wear and deformation occurring at the articular interface of a total hip replacement from sequential clinical radiographs. 1.2 This practice is primarily intended for use in evaluating patients receiving THRs composed of a polyethylene acetabular component articulating against a metal or ceramic femoral head. 1.3 So-called hard-on-hard articulations such as metal-on-metal and ceramic-on-ceramic THRs are not intended to be directly addressed. 1.4 This practice will focus on computer-assisted computational methodologies for measuring relative displacements over time, but not to the exclusion of other methodologies. 1.5 This practice describes methods for conducting a radiographic wear/creep study utilizing various computational methods and is not intended to promote or endorse a particular method. 1.6 It is not the intent of this practice to provide detailed instructions in the use of the various computational methods, which is contained in the respective user manuals. 1.7 It is the intent of this practice to enable comparisons of relative displacements occurring in groups of patients receiving different formulations of bearing materials. It must be recognized, however, that there are many possible variations in the in vivo conditions. A single clinical study may not be universally representative. 1.8 This practice is not intended to be a performance standard. It is the responsibility of the user of this practice to characterize the safety and effectiveness of the prosthesis under evaluation. 1.9 The values stated in SI units are to be regarded as the standard, with the exception of angular measurements, which may be reported in either degrees or radians. Additionally, pixel density may also be reported in imperial units. 1.10 The use of this standard may involve the operation of potentially hazardous radiographic equipment and does not purport to address the safety precautions associated with radiography. It is the responsibility of the user of this standard to define and establish appropriate safety practices. The standard does not determine the applicability of regulatory limitations prior to operating radiographic equipment. 1.11 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.12 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 This practice uses clinical radiographs of the hip joint of a patient that has received a total hip replacement to measure the combined effect of plastic deformation and wear at the articular interface which results in three-dimensional displacements of the femoral head into the acetabular component. 4.2 This practice addresses the validation of the various computational methods available for measuring the magnitude of creep/wear accruing at the articular surface of THRs. 4.3 This practice addresses the type of radiographic projections needed for an analysis as well as general radiographic parameters needed for obtaining high quality films. 4.4 This practice addresses the criterion for evaluating clinical radiographs for inclusion in a study. 4.5 This practice addresses the conversion of radiographic images to the appropriate digital format needed for the various computer-assisted computational methods.