• Eur Spine J · Sep 2016

    Comparative Study

    Preclinical evaluation of posterior spine stabilization devices: can the current standards represent basic everyday life activities?

    • Luigi La Barbera, Fabio Galbusera, Hans-Joachim Wilke, and Tomaso Villa.
    • Laboratory of Biological Structure Mechanics, Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, Piazza Leonardo da Vinci 32, 20133, Milan, Italy. luigi.labarbera@polimi.it.
    • Eur Spine J. 2016 Sep 1; 25 (9): 2909-18.

    PurposeTo discuss whether the available standard methods for preclinical evaluation of posterior spine stabilization devices can represent basic everyday life activities and how to compare the results obtained with different procedures.MethodsA comparative finite element study compared ASTM F1717 and ISO 12189 standards to validated instrumented L2-L4 segments undergoing standing, upper body flexion and extension. The internal loads on the spinal rod and the maximum stress on the implant are analysed.ResultsISO recommended anterior support stiffness and force allow for reproducing bending moments measured in vivo on an instrumented physiological segment during upper body flexion. Despite the significance of ASTM model from an engineering point of view, the overly conservative vertebrectomy model represents an unrealistic worst case scenario. A method is proposed to determine the load to apply on assemblies with different anterior support stiffnesses to guarantee a comparable bending moment and reproduce specific everyday life activities.ConclusionsThe study increases our awareness on the use of the current standards to achieve meaningful results easy to compare and interpret.

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