Assessment of the tolerance angle for pedicle screw insertion.

Cannulation process intervenes before implantation of pedicle screw and depends on the surgeon's experience. A reliable experimental protocol has been developed for the characterization of the slipping behavior of the surgical tool on the cortical shell simulated by synthetic materials. Three types of synthetic foam samples with three different densities were tested using an MTS Acumen 3 A/T electrodynamic device with a tri-axis 3 kN Kistler load cell mounted on a surgical tool, moving at a constant rotational speed of 10° mm and performing a three-step cannulation test. Cannulation angle varied between 10° and 30°. Synthetic samples were scanned after each tests, and cannulation coefficient associated to each perforation section was computed. Reproducibility tests resulted in an ICC for Sawbone samples of 0.979 (p < 0.001) and of 0.909 (p < 0.001) for Creaplast and Sawbone samples. Cannulation coefficient and maximum force in Z-axis are found the best descriptors of the perforation. Angular threshold for perforation prediction was found to be 17.5° with an area under the curve of the Receiver Operating Characteristic of 89.5%. This protocol characterizes the cannulation process before pedicle screw insertion and identifies the perforation tool angle until which the surgical tool slips on the cortical shell depending on bone quality.