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Computer simulating a clinical trial of a load-bearing implant: example of an intramedullary prosthesis
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.
Keyword(s): Bioengineering; Simulated clinical trials; Intramedullary fixation; Stochastic model; Finite element analysis; Mechanobiology; Next Generation Medical Devices
Publication Date:
Type: Journal article
Peer-Reviewed: Yes
Language(s): English
Institution: Trinity College Dublin
Citation(s): 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
First Indexed: 2014-05-13 05:10:52 Last Updated: 2015-07-15 05:29:06