Surface Damage in Machined Ram-Extruded and Net-Shape Molded Retrieved Polyethylene Tibial Inserts of Total Knee Replacements

A. Bērziņš, J. Jacobs, R. Berger, Chris Ed, R. Natarajan, T. Andriacchi, J. Galante
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引用次数: 42

Abstract

Background: Polyethylene wear has emerged as a major determining factor in the long-term clinical performance of total knee replacements. This study addresses the in vivo wear performance of two types of polyethylene tibial inserts used in similar total knee arthroplasty designs.Methods: A surface damage assessment of retrieved specimens was performed for twenty-six net-shape molded tibial inserts manufactured from H1900 resin without calcium stearate additive (Miller-Galante) and forty-three machined ram-extruded tibial inserts manufactured from GUR 4150 resin with calcium stearate additive (Miller-Galante II). Stereomicroscopic inspection and digital image analysis were used to quantify the extent and severity of pitting, dimensional change, and delamination.Results: Pitting and dimensional change were the most common modes of damage in both groups, with the prevalence ranging from 77% to 92% for pitting and from 51% to 81% for dimensional change. Delamination was the least common mode of damage, with the prevalence ranging from 21% to 35%. The severity of pitting was higher in association with the cemented implant-bone interface. The extent and severity of delamination increased with implantation time. No severe delamination was observed before sixty months after implantation in the net-shape molded group, whereas severe delamination was present as early as ten months after implantation in the machined ram-extruded group. The time between surgery and the discovery of damage was longer in the net-shape molded group for all modes of damage except for medial dimensional change.Conclusions: On the basis of the components available in our implant retrieval pool, we found that at equivalent levels of surface damage, the net-shape molded H1900 resin tibial inserts demonstrated longer service life than did the machined ram-extruded GUR 4150 components. The superior performance of the net-shape molded components may be related to the resin type, the absence of calcium stearate, the consolidation method, or the method of final geometry shaping. This superior damage resistance is expected to contribute to superior long-term clinical performance of net-shape molded ultra-high molecular weight polyethylene in total knee arthroplasty.
全膝关节置换术中机械冲压成形和网状模塑回收聚乙烯胫骨植入物的表面损伤
背景:聚乙烯磨损已成为全膝关节置换术长期临床表现的主要决定因素。本研究探讨了两种用于类似全膝关节置换术设计的聚乙烯胫骨植入物的体内磨损性能。方法:对未添加硬脂酸钙(Miller-Galante)的H1900树脂制造的26个网状成型胫骨插入件和添加硬脂酸钙(Miller-Galante II)的GUR 4150树脂制造的43个机械冲压胫骨插入件进行了表面损伤评估。采用立体显微镜检查和数字图像分析来量化点蚀、尺寸变化和分层的程度和严重程度。结果:点蚀和尺寸变化是两组中最常见的损伤模式,点蚀的患病率为77% ~ 92%,尺寸变化的患病率为51% ~ 81%。分层是最不常见的损伤模式,患病率为21%至35%。孔蚀的严重程度与种植体-骨界面的胶结有关。随着种植时间的延长,脱层的程度和严重程度增加。网状模塑组在植入后60个月前未见严重的脱层现象,而机械挤压组在植入后10个月出现严重的脱层现象。除内侧尺寸变化外,所有类型的损伤,网型模塑组从手术到发现损伤的时间都更长。结论:在我们的植入物检索池中可用的组件的基础上,我们发现在相同的表面损伤水平下,网状成型H1900树脂胫骨植入物的使用寿命比机械冲压成型GUR 4150组件更长。网状成型部件的优越性能可能与树脂类型、不含硬脂酸钙、固结方法或最终几何形状成型方法有关。这种优异的抗损伤性有望促进净形超高分子量聚乙烯模制全膝关节置换术中优越的长期临床性能。
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