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مجله رفتار مکانیکی مواد زیست پزشکی
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  • computer simulating a clinical trial of a load-bearing implant: an example of an intramedullary prosthesis

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    • تاریخ ارائه: 1394/01/01
    • تاریخ انتشار در تی پی بین: 1394/01/01
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     computational modelling is becoming ever more important for obtaining regulatory approval for new medical devices. an accepted approach is to infer performance in a population from an analysis conducted for an idealised or ‘average’ patient; we present here a method for predicting the performance of an orthopaedic implant when released into a population—effectively simulating a clinical trial. specifically we hypothesise that an analysis based on a method for predicting the performance in a population will lead to different conclusions than an analysis based on an idealised or ‘average’ patient. to test this hypothesis we use a finite element model of an intramedullary implant in a bone whose size and remodelling activity is different for each individual in the population. we compare the performance of a low young’s modulus implant (e = 20 gpa) to one with a higher young’s modulus (200 gpa). cyclic loading is applied and failure is assumed when the migration of the implant relative to the bone exceeds a threshold magnitude. the analysis for an idealised of ‘average’ patient predicts that the lower modulus device survives longer whereas the analysis simulating a clinical trial predicts no statistically-significant tendency (p = 0.77) for the low modulus device to perform better. it is concluded that population-based simulations of implant performance – simulating a clinical trial – present a very valuable opportunity for more realistic computational pre-clinical testing of medical devices.

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