Design and Research of Interspinous Lumbar Non-Fusion Device

Objective: Long term clinical data showed that lumbar fusion for Lumbar spinal stenosis (LSS) and lumbar disc degeneration (LDD) therapy could change the loads of disc and articular facet and increase the motion of adjacent segments which lead to facet arthropathy and adjacent level degeneration. This study is to design and analyze an interspinous process device (IPD) that could prevent adjacent level degeneration in the LSS and LDD therapy. Method: The IPD was designed based on anatomical parameters measured from 3D CT images directly. The IPD was inserted at the validated finite element model of the mono-segmental L3/L4. The biomechanical performance of a pair of interbody fusion cages and a paired pedicel screws were studied to compare with the IPD. The model was loaded with the upper body weight and muscle forces to simulate five loading cases including standing, compression, flexion, extension, lateral bending and axial rotation. Results: The interbody fusion cage induced serious stress concentration on the surface of vertebral body, has the worst biomechanical performance among the three systems. Pedicle screws and interbody fusion cage could induce stress concentration within vertebral body which leads to vertebral compression fracture or screw loosening. Regarding to disc protection, the IPD had higher percentage to share the load of posterior lumbar structure than the pedicel screws and interbody fusion cage. Conclusion: IPD has the same loads as pedicle screw-rod which suggests it has a good function in the posterior stability. While the IPD had much less influence on vertebral body. Furthermore, IPD could share the load of intervertebral discs and facet joints to maintain the stability of lumbar spine.