Spinal Pseudoarthrosis Mitigation Using Nano Devices

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 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.