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

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The broader impact/commercial potential of this project relates to thedevelopment of non-pharmacological interventions capable of improving clinicaloutcomes following spinal fusion surgery. Between 1998 and 2008, the annualnumber of spinal fusion surgeries increased 137% from 174,223 to 413,171 and thenational bill for spinal fusion increased 7.9-fold. The greatest risk in spinal fusionprocedures is failure to fuse, which can be particularly troublesome in high riskpatients. Failure to fuse leads to poor surgical outcomes for patients and may result inchronic pain, secondary surgical procedures, reduced productivity, and/or permanentdisability. In addition, failure to fuse results in greater clinical burden for physiciansand increased cost per patient for payers. Lumbar fusions, in particular, have acumulative reoperation rate of 19% over the 11 years following the initial procedure(BCC Research, 2010). The present project could result in the identification of newsurgical devices and techniques capable of improving surgical outcomes, reducingcomplications, and eliminating costs associated with unsuccessful surgery. Osteogenicsurgical device and techniques developed in the present project may also be used toaccelerate bone healing and improve clinical outcomes following fractures of the skull,face, and long bones.This Small Business Innovation Research (SBIR) Phase 2 project is todemonstrate in an animal model that osteogenic spinal instrumentation acceleratesnew bone formation and improves the rate of posterolateral fusion compared toclinically-accepted best practices in spinal fusion surgery. Innovative osteogenic spinalinstrumentation (pedicle screws, rods, etc.) facilitates both mechanical stabilization ofthe spine and focused delivery of fusion-stimulating direct electric current (DC) at thefusion site. Application of therapeutic stimuli via selectively anodized pedicle screwsaccelerates the rate at which new bone is formed in critical regions of the spine suchas the zygapophyseal joint and lateral gutter. The propensity of newly formed bone tocreate a robust, biomechanically sound fusion of adjacent vertebrae is also increasedunder osteogenic stimulation. Phase I results demonstrate that selectively-anodizedelectroactive pedicle screws effectively deliver focused osteogenic stimuli to keyregions of the lumbar spine critical to spinal fusion. Results provide computationalevidence for the technological and clinical success of novel osteogenicinstrumentation in spinal fusion surgery. Phase II will confirm that the system ofelectroactive spinal instrumentation has the potential to accelerate bone growth andimprove post-surgical fusion outcomes compared to gold-standard interventionsutilizing a clinically relevant large animal model.