A Biomechanical Evaluation of a Novel Interspinous Process Device: In Vitro Flexibility Assessment and Finite Element Analysis.

The interspinous process device (IPD) has emerged as a viable alternative for managing lumbar degenerative pathologies. Nevertheless, limited research exists regarding mechanical failure modes including device failure and spinous process fracture. This study developed a novel IPD (IPD-NEW) and systematically evaluated its biomechanical characteristics through finite element (FE) analysis and in vitro cadaveric biomechanical testing. Six human L1-L5 lumbar specimens were subjected to mechanical testing under four experimental conditions: (1) Intact spine (control); (2) L3-L4 implanted with IPD-NEW; (3) L3-L4 implanted with Wallis device; (4) L3-L4 implanted with Coflex device. Segmental range of motion (ROM) was quantified across all test conditions. A validated L1-L5 finite element model was subsequently employed to assess biomechanical responses under both static and vertical vibration loading regimes. Comparative analysis revealed that IPD-NEW demonstrated comparable segmental ROM to the Wallis device while exhibiting lower rigidity than the Coflex implant. The novel design effectively preserved physiological spinal mobility while enhancing load distribution capacity. IPD-NEW demonstrated notable reductions in facet joint forces, device stress concentrations, and spinous process loading compared to conventional implants, particularly under vibrational loading conditions. These findings suggest that IPD-NEW may mitigate risks associated with facetogenic pain, device failure, and spinous process fracture through optimized load redistribution.