Journal
JOURNAL OF THE MECHANICAL BEHAVIOR OF BIOMEDICAL MATERIALS
Volume 4, Issue 8, Pages 1880-1887Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jmbbm.2011.06.005
Keywords
Simulated clinical trials; Intramedullary fixation; Stochastic model; Finite element analysis; Mechanobiology
Funding
- Science Foundation Ireland
Ask authors/readers for more resources
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. (C) 2011 Elsevier Ltd. All rights reserved.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available