SBIR Phase I: High Strength, Surface Porous Devices for Improved Spinal Fusions

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel high strength, surface porous layer that can improve integration of non-metal orthopedic implants, resulting in better clinical outcomes. This improvement to orthopedic implants is especially important for lumbar fusion devices, which are used to alleviate chronic back and leg pain in over 240,000 patients annually. Non-metal, polymer implants are most commonly used for lumbar fusions because of their compatibility with medical imaging. However, these devices have smooth surfaces that do not integrate well with bone, which leads to a complication and revision surgery rate of approximately 11 to 15%. The proposed project will investigate the feasibility of the high strength, surface porous layer for use on lumbar fusion cages. The research objectives are to determine the effect the architecture of the surface porous layer has on the mechanical properties and the biological response for improved bone integration. The research will use standard mechanical tests to determine the static and fatigue properties of different polymer constructs with the surface porous layer and to determine the mechanical properties of the surface porous layer itself. Additionally, the research will use cell studies to determine the effect the porous layer architecture has on improving the osteoconductive response of cells to the implant surface. Finally, devices with the surface layer will be prototyped and tested under physiological conditions. It is anticipated that the architecture will have a minimal effect on bulk mechanical properties while significantly improving the osteoconductive response.