کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
811590 | 1469162 | 2009 | 8 صفحه PDF | دانلود رایگان |
The pre-clinical validation of new joint prostheses is an important step in the development process of a new implant design. The high success rate of modern prostheses makes it very difficult to ensure that new designs will exhibit significant improvements combined with a risk of failure as low as that of the designs currently in use. This situation requires a systematic re-thinking of the pre-clinical validation protocols. We advocate that a careful combination of risk analysis, experimental and numerical modelling, and the use of statistical finite element analysis to generalize the results to a simulated population, can provide the level of confidence required by class 3 devices as the joint prostheses recently became. The proposed approach is illustrated using the validation of a cemented epiphyseal stem as an example.
Journal: Journal of the Mechanical Behavior of Biomedical Materials - Volume 2, Issue 1, January 2009, Pages 120–127