Integrating computational evaluation and mechanical testing to optimize laser-sintered polyether ketone scaffolds for mandibular reconstruction in large animal models.

Critical-sized mandibular defects require reconstruction strategies that restore mechanical function while avoiding the limitations of bone grafting and metallic fixation. This study aimed to optimize the mechanical performance of laser-sintered polyether ketone (LS-PEK) scaffolds using an integrated computational and experimental approach. Three scaffold geometries with different bone-implant interface designs (straight-cut/non-curved, straight-cut/curved, and wedge-cut/curved) were evaluated using image-based finite element analysis and extended finite element method (XFEM) fracture simulations, alongside in vitro mechanical testing in cadaveric ovine mandibles. Computational results showed that interface geometry strongly influenced stress distribution and deformation, with the wedge-cut/curved design exhibiting the lowest peak stress and the most uniform stress distribution. Mechanical testing under simulated mandibular loading conditions confirmed these findings, with the wedge-cut scaffold demonstrating higher load-bearing capacity and greater deformation prior to failure. Further, failure in the wedge-cut scaffold consistently initiated in the native bone rather than the scaffold, indicating improved load transfer and reduced stress concentration. XFEM simulations predicted crack initiation sites and propagation patterns that correlated well with experimentally observed failure modes, supporting the validity of the computational framework. Overall, these results demonstrate that geometric optimization of LS-PEK scaffolds enhances mechanical performance, with the wedge-cut/curved design providing improved load sharing and fracture resistance, supporting its potential for patient-specific mandibular reconstruction applications requiring mechanically robust load-bearing implants. Further biological evaluation, including osseointegration, vascularization, fatigue performance, and long-term in vivo response, will be required to confirm translational suitability.