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The success of surgical treatment for fractures hinges on various factors, notably accurate surgical indication. The process of developing and certifying a new osteosynthesis device is a lengthy and costly process that requires multiple cycles of review and validation. Current methods, however, often rely on predecessor standards rather than physiological loads in specific anatomical locations. This study aimed to determine actual loads experienced by an osteosynthesis plate, exemplified by a standard locking plate for the femoral shaft, utilizing finite elements analysis (FEA) and to obtain the bending moments for implant development standard tests. A protocol was developed, involving the creation and validation of a fractured femur model fixed with a locking plate, mechanical testing, and FEA. The model's validation demonstrated exceptional accuracy in predicting deformations, and the FEA revealed peak stresses in the fracture bridging zone. Results of a parametric analysis indicate that larger fracture gaps significantly impact implant mechanical behavior, potentially compromising stability. This study underscores the critical need for realistic physiological conditions in implant evaluations, providing an innovative translational approach to identify internal loads and optimize implant designs. In conclusion, this research contributes to enhancing the understanding of implant performance under physiological conditions, promoting improved designs and evaluations in fracture treatments.
Mühling et al. (2024) studied this question.