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Influence of Exogenous Variables on Intrusion Depth of PMMA Bone Cement: Revision of ISO 5833 Standard | Bentham Science

机译:外在变量对PMMA骨水泥侵入深度的影响:修订ISO 5833标准|边沁科学

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Background: Poly (methyl methacrylate) (PMMA) bone cement is widely used to anchortotal joint replacements to the contiguous bone. Among the clinically-relevant properties of this materialis its intrusion depth (ID) because it indicates the potential for interdigitation of the curing cementinto the interstices of the cancellous bone. ID is determined using procedures stipulated in ISO5833. There is only one study in which ISO 5833 was examined critically, but only one exogenousvariable was considered.Purpose: We carried out an extensive critical analysis of the ISO 5833 Standard with a view to makingrecommendations for revising it.Materials and Methods: 7 approved PMMA bone cement brands (covering low-, medium-, andhigh-viscosity brands) were used in two series of tests. In the first series, the influence of time atwhich ID was determined (relative to achievement of cement doughing time (DT)) was delineated. Inthe second series, the influence of three clinically-relevant variables on ID for each of these brandswas determined and, then, response surface methodology was used to analyze the results.Results: ID results are given for both series of tests. Over the range of the variables used, the optimumIDs for a low-, medium-, and high-viscosity brand were computed to be 5.7 mm, 3.1 mm, and2.4 mm, respectively.Conclusion: The findings allowed us to recommend that the following revisions be made to stipulationsin ISO 5833 for determining ID: prior to running the ID test, store the cement unit at 1°C; 60minutes after removing the cement unit from the storage medium, mix the cement powder and liquid,in a vacuum chamber, at 120 rpm; and determine ID 3 minutes after DT is achieved.
机译:背景:聚(甲基丙烯酸甲酯)(PMMA)骨水泥被广泛用于将全关节置换物锚定到邻近的骨上。这种材料的临床相关特性之一是其侵入深度(ID),因为它表明了固化胶结物相互交叉到松质骨空隙中的潜力。 ID是使用ISO5833规定的程序确定的。仅有一项研究对ISO 5833进行了严格审查,但仅考虑了一个外源变量目的:我们对ISO 5833标准进行了广泛的严格分析,以提出对其进行修订的建议材料和方法:7个已批准的PMMA在两个系列的测试中使用了骨水泥品牌(包括低,中和高粘度品牌)。在第一个系列中,描述了确定ID的时间的影响(相对于水泥生面团时间(DT)的实现)。在第二个系列中,确定了三个临床相关变量对这些品牌中每个品牌的ID的影响,然后使用响应面分析法对结果进行了分析。结果:两个系列的测试均给出了ID结果。在所使用的变量范围内,低,中和高粘度品牌的最优ID分别计算为5.7 mm,3.1 mm和2.4 mm。结论:研究结果使我们建议对ISO 5833中确定ID的规定进行了以下修订:在进行ID测试之前,将水泥单元存放在1°C下;从储存介质中取出水泥单元后60分钟,在真空室内以120 rpm的速度混合水泥粉和液体。并在实现DT后3分钟确定ID。

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