ISO 12189 standard for the preclinical evaluation of posterior spinal stabilization devices – I: Assembly procedure and validation

Abstract

The International Standardization Organization introduced standard 12189 for the preclinical evaluation of the mechanical reliability of posterior stabilization devices. The well-known vertebrectomy model formalized in standard F1717 by the American Society for Testing and Materials was modified with the introduction of a modular anterior support made up of three calibrated springs, which allows to describe a more realistic scenario, closer to the effective clinical use, as well to test even very flexible and dynamic posterior stabilization implants. Despite these important improvements, ISO 12189 received very little attention in the literature. The aim of the work is to provide a systematic procedure for the assembly and validation of a finite element model capable of describing the experimental test according to ISO 12189. The validated finite element model is able to catch very well the effective stiffness of the unassembled and assembled constructs (percentage differences <2% and <10%, respectively). As concern the assembled construct, the experimentally measured and predicted strains were found in a good agreement (R² > 0.75, root mean square error < 30%), but the procedure without precompression lead to much better results (R² > 0.96, root mean square error < 10%). Given the prediction errors of the assembled construct fall within the experimental range of repeatability, the finite element model can be systematically implemented to support the mechanical design of a variety of spinal implants, to quantitatively investigate the load-sharing mechanism, as well as to investigate the loading conditions set by ISO 12189 standard.