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

该项目更广泛的影响/商业潜力是，脊柱融合手术临床成功的显著改善，灾难性并发症和二次手术风险的降低，术后生活质量的改善，以及脊柱手术和脊柱护理日益增长的成本的降低。1998至2008年间，每年脊柱融合手术的数量增加了137%，从174,223例增加到413,171例，国家用于脊柱融合的账单增加了7.9倍。S成骨脊柱内固定具有显著提高术后后外侧融合率的潜力。通过在对脊柱稳定至关重要的区域诱导局部骨形成，这种新型器械降低了骨不连的风险，从而降低了昂贵的二次手术和程序的风险。初步的动物模型数据表明，OsteoVantage内固定可以将融合率提高一倍，这意味着95%以上的病例融合更成功，并有可能将融合失败的风险降低4倍-8倍。随后，OsteoVantage？S独特的脊柱内固定设备旨在消除75%的二次手术程序(每个病例约50,000美元)，并减少对慢性疼痛管理和姑息治疗的需求。在未来的迭代中，OsteoVantage？S技术可能会为更多的患者群体提供显著的好处。这个小企业创新研究(SBIR)第一阶段项目将专注于开发一种新型的电动椎弓根螺钉，能够促进对外侧沟槽和关节突关节的治疗性直流电刺激，从而促进人类脊柱的骨形成和后外侧融合。将微电脉冲集中传递到人体脊椎具有加速局部骨形成和节段间愈合的独特能力。然而，能够向脊柱提供直流电刺激的脊柱内固定设备的设计仍然是结束手术使用和有效临床转换的关键因素。本项目旨在构建和实施人体脊柱的计算电生理模型，并评估最优的椎弓根螺钉设计，以促进对脊柱后部解剖的聚焦直流电刺激。选择性阳极化椎弓根螺钉将作为一种将治疗性电刺激引导和聚焦到内固定脊柱后部解剖区域的方法进行评估。开发一种独特的针对后外侧融合进行优化的电动椎弓根螺钉将提高现有电动器械系统的临床实用性，并显着降低该技术进一步商业化的风险。预期的结果将是确定用于临床前动物试验的最佳椎弓根螺钉设计。

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.