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[翻修的聚乙烯Bicon-Plus髋臼杯的轴承表面磨损与粗糙度]

[Wear and Roughness of Bearing Surface in Retrieved Polyethylene Bicon-Plus Cups].

作者信息

Ranuša M, Gallo J, Hobza M, Vrbka M, Nečas D, Hartl M

机构信息

Ústav konstruování, Fakulta strojního inženýrství, Vysoké učení technické v Brně.

出版信息

Acta Chir Orthop Traumatol Cech. 2017;84(3):159-167.

Abstract

PURPOSE OF THE STUDY By 7th December 2016, 4,755 Bicon-Plus cups in total were implanted in the Czech Republic. Some of them have been continuously re-operated, while the most frequent reason of failure is polyethylene wear and aseptic loosening. The present study is focused on surface analysis of retrieved polyethylene Bicon-Plus cups and the determination of the roughness of their bearing surfaces. MATERIAL AND METHODS In this study, we had 13 high molecular weight polyethylene cups with the average time in situ of 8.11 years (3.6-13.7, SD 3.2) before the retrieval. The study population was composed of 3 men, 10 women, with the mean age of 53.31 years. An optical scanning method, based on the principle of active triangulation, was used to determine wear rate. The rate of wear was identified by means of an obtained scan subsequently processed with the use of the GOM Inspect software. The roughness of surfaces was analysed with the application of Contour GT-X8 profiler using the principle of phase shifting interferometry. Measurements of surface topography of the retrieved cups were performed on the entire bearing surfaces. For the individual surface changes, a typical range of surface roughness, describing the particular wear character, was determined. By means of morphology analysis of the tested implants, three areas were identified: unworn area; area representing the worn part of the cup; and the area roughened by parallel grooving. The total surface roughness was evaluated as an arithmetic mean of the measured values. Subsequently, the values were sorted based on frequency and were classified into categories defining the particular wear mechanisms. RESULTS Wear rate of the retrieved acetabular cups was evaluated based on the wear direction vector and the size of linear wear. The average linear wear was equal to 0.13 mm/year (ranging from 0.26 to 2.29 mm/year), and the mean value of total volumetric material loss was 44.37 mm3/year (the range being from 51.80 to 1,119.7 mm3/year). Using the optical profilometer, a map of roughness distribution of the individual cups was obtained. For each implant, 76 values of roughness were evaluated. With the respect to average roughness, the samples were sorted to various categories describing: surface polishing; abrasiveadhesive wear; surfaces with preserved grooving; substantial plastic deformation. DISCUSSION The results clearly showed an increase of wear depending on implant survival; however, the tendency is not linear. This fact can be attributed to a larger amount of abrasive particles, causing an increase of wear or occurrence of surface wear in terms of micro cracks and oxidation degradation of polyethylene. This study indicates that geometry, positioning, and cup alignment during the implantation have a fundamental impact on the cup durability. Further correlation, which was observed in the case of the cup with prevailing roughness in the range from 0.1 to 0.3 μm, is a relatively wide wear vector angle determined with the use of the optical method. Considering the implants with the longest survival time with no loosening of the acetabular cup, the mean angle of direction vector was 56.8° (SD 2.1°). CONCLUSIONS The present study provides the results of morphology analysis of the retrieved Bicon-Plus cups. In general, relatively high wear rate, mainly of abrasive-adhesive character was identified. The dependence between wear and implant in situ longevity was not clearly linear, which suggests the influence of other parameters on the polyethylene wear rate. An important role of implant positioning on survival was also revealed. Moreover, it seems that it can be a more important parameter than the characteristics of the patient. Key words: total hip arthroplasty, Bicon-Plus cup, retrieval analysis, surface analysis, wear measurement, roughness, deformation, survivorship.

摘要

研究目的 截至2016年12月7日,捷克共和国共植入了4755个Bicon-Plus髋臼杯。其中一些已多次进行翻修手术,而最常见的失败原因是聚乙烯磨损和无菌性松动。本研究聚焦于回收的聚乙烯Bicon-Plus髋臼杯的表面分析及其承重面粗糙度的测定。材料与方法 在本研究中,我们有13个高分子量聚乙烯髋臼杯,回收前在位平均时间为8.11年(3.6 - 13.7年,标准差3.2)。研究对象包括3名男性和10名女性,平均年龄为53.31岁。采用基于主动三角测量原理的光学扫描方法来确定磨损率。通过对获得的扫描图像进行处理,利用GOM Inspect软件确定磨损率。使用相移干涉测量原理的Contour GT-X8轮廓仪分析表面粗糙度。对回收髋臼杯的整个承重面进行表面形貌测量。针对个体表面变化,确定了描述特定磨损特征的典型表面粗糙度范围。通过对测试植入物的形态分析,确定了三个区域:未磨损区域;代表髋臼杯磨损部分的区域;以及因平行沟槽而粗糙化的区域。总表面粗糙度以测量值的算术平均值进行评估。随后,根据频率对这些值进行排序,并分类为定义特定磨损机制的类别。结果 根据磨损方向向量和线性磨损大小评估回收髋臼杯的磨损率。平均线性磨损为0.13毫米/年(范围为0.26至2.29毫米/年),总体积材料损失的平均值为44.37立方毫米/年(范围为51.80至1119.7立方毫米/年)。使用光学轮廓仪获得了各个髋臼杯的粗糙度分布图。对于每个植入物,评估了76个粗糙度值。根据平均粗糙度,将样本分类为描述不同情况的类别:表面抛光;磨粒 - 粘着磨损;保留沟槽的表面;大量塑性变形。讨论 结果清楚地表明,磨损随植入物存活时间增加,但趋势并非线性。这一事实可归因于大量磨粒,导致磨损增加或出现表面磨损,如聚乙烯的微裂纹和氧化降解。本研究表明,植入过程中的几何形状、位置和髋臼杯对线对髋臼杯的耐久性具有根本性影响。在粗糙度主要在0.1至0.3微米范围内的髋臼杯案例中观察到的进一步相关性是,通过光学方法确定的磨损向量角相对较宽。考虑到髋臼杯存活时间最长且未松动的植入物,方向向量的平均角度为56.8°(标准差2.1°)。结论 本研究提供了回收的Bicon-Plus髋臼杯的形态分析结果。总体而言,确定了相对较高的磨损率,主要为磨粒 - 粘着性质。磨损与植入物在位寿命之间的依赖关系并非明显线性,这表明其他参数对聚乙烯磨损率有影响。还揭示了植入物位置对存活的重要作用。此外,似乎它可能是比患者特征更重要的参数。关键词:全髋关节置换术;Bicon-Plus髋臼杯;回收分析;表面分析;磨损测量;粗糙度;变形;存活率

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