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

该项目更广泛的影响/商业潜力涉及到能够改善脊柱融合手术后临床结果的非药物干预措施的发展。从1998年到2008年，每年脊柱融合术的数量从174223例增加到413171例，增加了137%，全国脊柱融合术的费用增加了7.9倍。脊柱融合术中最大的风险是融合失败，这在高风险患者中尤其麻烦。融合失败会导致患者手术效果不佳，并可能导致慢性疼痛、二次手术、生产力下降和/或永久性残疾。此外，未能融合会导致医生的临床负担加重，支付方的每位患者成本增加。特别是腰椎融合术，在首次手术后的11年中，累计再手术率为19% （BCC Research, 2010）。目前的项目可能导致识别新的手术设备和技术，能够改善手术结果，减少并发症，并消除与手术失败相关的费用。本项目开发的成骨外科设备和技术也可用于加速颅骨、面部和长骨骨折后的骨愈合和改善临床结果。这个小企业创新研究（SBIR）第二阶段项目是在动物模型中证明，与临床接受的脊柱融合手术最佳实践相比，成骨脊柱内固定加速新骨形成并提高后外侧融合率。创新的成骨脊柱内固定（椎弓根螺钉、棒等）既有利于脊柱的机械稳定，又有利于在融合部位集中输送刺激融合的直流电流（DC）。通过选择性阳极化椎弓根螺钉施加治疗性刺激可加快脊柱关键部位（如关节突关节和侧沟）新骨形成的速度。在成骨刺激下，新形成的骨产生健壮的、生物力学上良好的相邻椎体融合的倾向也会增加。一期研究结果表明，选择性阳极电活性椎弓根螺钉可有效地向腰椎关键区域提供集中的成骨刺激，对脊柱融合至关重要。结果为新型成骨内固定在脊柱融合手术中的技术和临床成功提供了计算证据。II期研究将证实，与采用临床相关大型动物模型的金标准介入相比，电脊柱内固定系统具有加速骨生长和改善术后融合结果的潜力。

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.