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

这个小型企业创新研究(SBIR)第一阶段项目将开发一种选择性直流透气性椎弓根螺钉表面，用于正在申请专利的成骨脊柱融合器械。新型骨基质在电场作用下能更快地将骨移植材料结合在一起，形成牢固的、生物力学性能良好的节段间愈合。当螺丝钉将电流输送到骨中时，由于局部成骨作用，螺纹钉周围的锚固强度也会增加。椎弓根螺钉松动是与脊柱融合手术相关的临床不可接受的失败率(20-40%)的一个因素。根据初步工作，拟议的仪器系统有可能通过提高融合率和稳健性来显著改善结果。精确控制通过椎弓根螺钉传递的电场是优化成骨能力所必需的。该项目更广泛的影响/商业潜力是开发商业可用的成骨器械，有可能改善手术结果，从而减少额外手术的高发生率、慢性疼痛和与融合失败相关的成本。在未来的迭代中，它可能被用于加速颅骨、面部和其他部位的骨折修复。因为骨修复机制在不同物种之间是相似的，有朝一日它可能会为兽医整形外科医生提供一种帮助他们的动物病人的方法。

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.