Spinal Pseudoarthrosis Mitigation Using Nano Devices

 描述（由申请人提供）：该项目提供了一种新的策略和技术平台，可在非融合/假关节的情况下实现持久的脊柱稳定。该团队建议开发新型纳米管增强微米多孔椎间融合器（IFD）和纳米管增强椎弓根螺钉作为脊柱重建的固定器械。预计该技术将加速并最大限度地提高新骨形成和骨-植入物固定强度，从而在没有桥接骨的情况下持久稳定脊柱节段-可能降低老年患者假关节相关并发症的重大人类和社会成本。在这项研究中，该团队首先提出评估安全性问题，如长期磨损和材料分层的风险，然后在体外评估材料对骨细胞的亲和力，最后在体内评估植入物（IFD和椎弓根 螺钉）对绵羊模型中骨固定强度的影响。该团队还建议评估一种新的假关节动物模型的可行性，该模型将用于评估长期稳定的耐久性以及减少假关节的严重和昂贵并发症。重要的是，目前骨科市场上没有经过FDA正式审查和批准的纳米技术标记植入物，并且缺乏专注于长期磨损碎屑分析和减少假关节并发症的商业化转化研究。该项目将为监管机构提供重要的翻译数据，然后植入纳米技术才能向前发展，并用于造福社会的产品。

 DESCRIPTION (provided by applicant): This project presents a novel strategy and technology platform to achieve durable spinal stabilization despite non-fusion/pseudoarthrosis. The team proposes to develop novel nanotube enhanced micron porous interbody fusion devices (IFDs) and nanotube enhanced pedicle screws as fixation devices for spinal reconstruction. The technology is expected to speed up and maximize new bone formation and bone-to-implant fixation strength to durably stabilize spine segments in the absence of bridging bone - potentially reducing the significant human and societal costs of pseudoarthrosis-related complications in aging patients. In this study, the team first proposes to assess safety issues such as long term wear generation and risk of delamination of the material, then evaluate in vitro the affinity of materials to bone cells, and finally assess in vivo implant (IFDs and pedicle screws, respectively) to bone fixation strength in sheep models. The team also proposes to assess the feasibility of a new pseudoarthrosis animal model which would be used to assess the durability of stabilization over a longer term and the reduction in the severe and costly complications of pseudoarthrosis. Importantly there are no formally FDA reviewed and cleared nano technology labeled implants in the orthopedic market today and there is a lack of commercially oriented translational research focusing on long term wear debris analysis and reductions in complications of pseudoarthrosis. This project will provide regulators important translational data before implant nanotechnology can move forward and be used in products that benefit society.