Strength⁻Durability Correlation of Osteosynthesis Devices Made by 3D Layer Manufacturing.

To develop orthopedic implants that are optimized for each patient's needs or skeletal structure (custom-made implants), evaluations of the bending strength, bending stiffness, and durability of various types of conventional osteosynthesis devices have become important. Four-point bending tests and compression bending tests of osteosynthesis devices (bone plates, intramedullary nail rods, spinal rods, compression hip screws (CHSs), short femoral nails, and metaphyseal plates) were carried out to measure their bending stiffness, bending strength, and durability. The bending stiffness of bone plates, intramedullary nails, spinal rods, CHSs, short femoral nails, and metaphyseal plates increased with increasing bending strength. The durability limit of various types of osteosynthesis devices linearly increased with increasing bending strength. The relationship (durability limit at 10⁶ cycles) = 0.67 × (bending strength) (N·m) (R² = 0.85) was obtained by regression. The relationship for the highly biocompatible Ti-15Zr-4Nb-4Ta alloy was also linear. The mechanical strength and ductility of specimens that were cut from various osteosynthesis devices were excellent and their microstructures consisted of fine structures, which were considered to be related to the excellent durability. These results are expected to be useful for the development of implants suitable for the skeletal structure of patients using three-dimensional (3D) layer manufacturing technologies.