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Computer simulating a clinical trial of a load-bearing implant: example of an intramedullary prosthesis |
PRENDERGAST, PATRICK
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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 in an idealized 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 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 () 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 in an idealized 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?presents a very valuable opportunity for more realistic computational pre-clinical testing of medical devices.
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Keyword(s):
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Bioengineering; Simulated clinical trials; Intramedullary fixation; Stochastic model; Finite element analysis; Mechanobiology; Next Generation Medical Devices |
Publication Date:
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2011 |
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Type:
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Journal article |
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Peer-Reviewed:
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Yes |
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Language(s):
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English |
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Institution:
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Trinity College Dublin |
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Citation(s):
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P.J. Prendergast, P.E. Galibarov, C. Lowrey, A.B. Lennon, Computer simulating a clinical trial of a load-bearing implant: example of an intramedullary prosthesis, Journal of the Mechanical Behavior of Biomedical Materials, 4, 8, 2011, 1880 1887 |
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First Indexed:
2014-05-13 05:10:52 Last Updated:
2015-07-15 05:29:06 |
