SBIR Phase I: Development of Osteogenic Pedicle Screws for Posterolateral Spinal Fusion

The broader impact/commercial potential of this project is a dramatic improvement in the clinical success of spinal fusion surgery, decrease in the risk of catastrophic complications and secondary procedures, improvement in quality of life post-operatively, and reduction in the growing cost of spinal surgery and spine care. Between 1998 and 2008, the annual number of spinal fusion surgeries increased 137% from 174,223 to 413,171 and the national bill for spinal fusion increased 7.9 times. OsteoVantage?s osteogenic spinal instrumentation has the potential to dramatically improve the rate of posterolateral fusion following surgery. By inducing focal bone formation in areas critical to spine stability, the novel instrumentation reduces the risk of non-union, and thereby the risk of costly secondary surgeries and procedures. Preliminary animal model data suggest that OsteoVantage instrumentation can double the rate of fusion, which translates to a more successful fusion in over 95% of cases, and potentially a 4X-8X reduction in the risk of failed fusion. Subsequently, OsteoVantage?s unique spinal instrumentation is targeted at eliminating >75% of secondary surgical procedures (approximately $50,000 per case) and reducing the need for chronic pain management and palliative care. In future iterations, OsteoVantage?s technology may provide significant benefit to additional patient populations. This Small Business Innovation Research (SBIR) Phase I project will focus on the development of a novel electroactive pedicle screw capable of facilitating therapeutic DC electrical stimulation of the lateral gutter and zygapophyseal joints and thereby enhancing bone formation and posterolateral fusion of the human spine. Focal delivery of microelectric impulses into human vertebrae has the unique ability to accelerate focal bone formation and enable intersegmental union. Yet, the design of spinal instrumentation capable of delivering DC electrical stimulation to the spine remains a critical factor to end surgical use and effective clinical translation. The present project aims to construct and implement a computational electrophysiological model of the human spine and evaluate optimal pedicle screw designs which facilitate focal DC electrical stimulation of the posterior spinal anatomy. Selectively-anodized pedicle screws will be evaluated as a means of routing and focusing therapeutic electrical stimulation to posterior anatomical regions of the instrumented spine. Development of a unique electroactive pedicle screw optimized for posterolateral fusion will improve the clinical utility the present system of electroactive instrumentation and significantly de-risk further commercialization of the technology. The expected outcome will be the identification of an optimal pedicle screw design for use in pre-clinical animal testing.