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低成本动力加压接骨板的力学行为与制造质量标准相关。

Mechanical behaviour of low-cost dynamic compression plates correlates with manufacturing quality standards.

机构信息

Biomechanics Laboratory of San Francisco General Hospital, San Francisco, CA, USA.

出版信息

Int Orthop. 2014 Jan;38(1):141-7. doi: 10.1007/s00264-013-2148-2. Epub 2013 Dec 4.

Abstract

PURPOSE

This study compares the mechanical properties of low-cost stainless steel dynamic compression plates (DCPs) from developing-world manufacturers, adhering to varying manufacturing quality standards, with those of high-cost DCPs manufactured for use in the developed world.

METHODS

Standard-design ten-hole DCPs from six developing-world manufacturers and high-cost DCPs from two manufacturers in the developed world were studied. Nine plates from each manufacturer underwent mechanical testing: six in four-point monotonic bending to assess strength and stiffness and three in four-point bending fatigue. Statistical comparisons of the group means of monotonic bending test data were made, and a qualitative comparison was performed to assess failures in fatigue.

RESULTS

Low-cost DCPs from manufacturers with at least one manufacturing quality standard had significantly higher bending strength and fewer failures in fatigue than did those from low-cost manufacturers with no recognised quality standards. High-cost DCPs demonstrated greater bending strength than did those in both low-cost groups. There were no differences in stiffness and fatigue failure between high-cost DCPs and those low-cost DCPs with quality standards. However, high-cost DCPs were significantly less stiff and had fewer fatigue failures than low-cost DCPs manufactured without such standards.

CONCLUSION

Significant differences were found in the mechanical properties of ten-hole DCP plates from selected manufacturers in the developing and developed worlds. These differences correlated with reported quality certification in the manufacturing process. Mechanical analysis of low-cost implants may provide information useful in determining which manufacturers produce implants with the best potential for benefit relative to cost.

摘要

目的

本研究比较了来自发展中国家制造商的低成本不锈钢动力加压接骨板(DCP)与发达国家制造商生产的高成本 DCP 的机械性能,这些制造商符合不同的制造质量标准。

方法

研究了来自六个发展中国家制造商的标准设计十孔 DCP 和来自两个发达国家制造商的高成本 DCP。对每个制造商的 9 个板进行了机械测试:6 个进行四点单调弯曲测试以评估强度和刚度,3 个进行四点弯曲疲劳测试。对单调弯曲测试数据的组平均值进行了统计比较,并进行了定性比较以评估疲劳失效情况。

结果

至少有一个制造质量标准的低成本 DCP 的弯曲强度显著高于没有公认质量标准的低成本制造商的 DCP,且疲劳失效更少。高成本 DCP 的弯曲强度大于两个低成本组的 DCP。在刚度和疲劳失效方面,高成本 DCP 与具有质量标准的低成本 DCP 之间没有差异。然而,高成本 DCP 的刚度显著降低,且疲劳失效比没有这种标准的低成本 DCP 更少。

结论

在来自发展中国家和发达国家的选定制造商的十孔 DCP 板的机械性能方面发现了显著差异。这些差异与制造过程中的报告质量认证相关。对低成本植入物的机械分析可能提供有用的信息,有助于确定哪些制造商生产的植入物具有相对于成本的最佳潜在益处。

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