Testing criteria for spinal implants: recommendations for the standardization of in vitro stability testing of spinal implants.
Testing criteria for spinal implants: recommendations for the standardization of in vitro stability testing of spinal implants.
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DOI：
10.1007/s005860050045
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发表时间：
1998-01-01
期刊：
影响因子：
--
通讯作者：
Claes, L
中科院分区：
文献类型：
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作者：
Wilke, H J;Wenger, K;Claes, L
新的植入物和新的手术方法应该在标准化的实验室测试中进行体外初步稳定性测试，以便在接受临床使用之前决定最合适的方法。由于脊柱在体内的载荷复杂且尚不清楚，因此使用了各种不同的测试载荷条件，使得不同组的结果几乎不可能进行比较。这一建议是在与研究科学家、整形外科和创伤外科医生以及脊柱植入公司的研发主管举行的一系列研讨会上提出的。目的是就体外测试条件达成一致，以便对不同研究小组的结果进行比较。本文介绍了这些研讨会推荐的加载方法、样品条件和分析参数。
New implants and new surgical approaches should be tested in vitro for primary stability in standardized laboratory tests in order to decide the most appropriate approach before being accepted for clinical use. Due to the complex and still unknown loading of the spine in vivo a variety of different test loading conditions have been used, making comparison of the results from different groups almost impossible. This recommendation was developed in a series of workshops with research scientists, orthopedic and trauma surgeons, and research and development executives from spinal implant companies. The purpose was to agree on in vitro testing conditions that would allow results from various research groups to be compared. This paper describes the recommended loading methods, specimen conditions, and analysis parameters resulting from these workshops.