SBIR Phase I: Development of a Selectively Current-permeable Osteogenic Pedicle Screw Surface for Vertebral Fusion

This Small Business Innovation Research (SBIR) Phase I project will develop a selectively direct-current permeable pedicle screw surface for use with patent-pending osteogenic spinal fusion instrumentation. New bone matrix more rapidly incorporates the bone graft material in the presence of an electric field to form a robust, biomechanically sound, intersegmental union. As the screw transmits current into the bone, peri-screw anchorage strength is also increased because of the local osteogenic effects. Pedicle screw loosening is a factor that contributes to clinically unacceptable failure rate (20-40%) associated with spinal fusion surgery. Based on preliminary work, the proposed instrumentation system has the potential to significantly improve outcomes by increasing fusion rate and robustness. Precise control of the electric field delivered through the pedicle screws is necessary to optimize the osteogenic capabilities. The broader impact/commercial potential of this project is the development of commercially available osteogenic instrumentation with the potential to improve surgical outcomes, thus reducing the high incidence of additional surgery, chronic pain and cost associated with failed fusion. In future iterations, it could potentially be used to accelerate fracture repair of the skull, face, and other sites. Because bone repair mechanisms are similar across species, it may one day offer veterinary orthopedic surgeons a means to help their animal patients.