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

该小型企业创新研究（SBIR）I期项目将开发一种选择性直流可渗透椎弓根螺钉表面，用于正在申请专利的成骨脊柱融合器械。新骨基质在电场存在下更快地结合骨移植材料，以形成坚固的、生物力学上合理的节段间愈合。当螺钉将电流传输到骨中时，由于局部成骨效应，螺钉周围锚固强度也增加。椎弓根螺钉松动是导致脊柱融合手术相关临床不可接受的失败率（20-40%）的一个因素。基于初步工作，所提出的仪器系统有可能通过提高融合率和鲁棒性来显著改善结果。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/商业潜力是开发市售的成骨器械，其有可能改善手术结果，从而降低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。由于骨修复机制在不同物种之间是相似的，有一天它可能会为兽医整形外科医生提供一种帮助动物患者的方法。

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.