Design of a Dynamic Stabilization Spine Implant

Abstract

Arthritis, degenerative disc disease, spinal stenosis, and other ailments lead to the deterioration of the facet joints of the spine, causing pain and immobility in patients. Dynamic stabilization and arthroplasty of the facet joints have advantages over traditional fusion methods by eliminating pain while maintaining normal mobility and function. In the present work, a novel dynamic stabilization spine implant design was developed using computational analysis, and the final design was fabricated and mechanically tested. A model of a fused L4–L5 Functional Spinal Unit (FSU) was developed using Pro/Engineer (PTC Corporation, Needham, MA). The model was imported into commercial finite element analysis software Ansys (Ansys Inc., Canonsburg, PA), and meshed with the material properties of bone, intervertebral disc, and titanium alloy. Physiological loads (600N axial load, 10 N-m moment) were applied to the model construct following the protocol developed by others. The model was subjected to flexion/extension, axial rotation, and lateral bending, and was validated with the results reported by Kim et al. The validated FSU was used as a base to design and evaluate novel spine implant designs, using finite element anlysis. A comparison of the flexion-extension curve of six designs and an intact spine was carried out. Range of motion of the new designs showed up to 4 degrees in flexion and extension, compared to less than one degree flexion/extension in a fused spine. The design that reproduced normal range of motion best was optimized, fabricated and prepared for mechanical testing. The finalized dynamic stabilization design with spring insert was implanted into a L4-L5 FSU sawbone (Pacific Research Laboratories, Vashon, WA) using Stryker Xia pedicle screws. The construct was potted using PMMA, and was subjected to flexion/extension, axial rotation, and lateral bending loads using MTS mechanical testing machine. The stiffness of the design was assessed and compared with computational analysis results.