Research Project
8831032
DESCRIPTION (provided by applicant): The team proposes to evaluate and commercialize an innovative technology platform capable of stabilizing a spine segment despite non-fusion/pseudoarthoris. To do that, the team proposes to complete development of (i) a customized titanium dioxide nanotube surface for optimized osseointegration, (ii) a micro-porous titanium scaffold coated PEEK substrate to allow bone ingrowth and direct apposition, and (iii) a hierarchical combination of the two technologies to create a macro- micro-nano porous implant, a interbody fusion device. The technology is expected to speed and maximize new bone formation and bone-to-implant fixation strength to durably stabilize spine segments in the absence of bridging bone, obviating the significant human and societal cost of pseudoarthrosis- related complications. The team has encouraging data from our pilot ovine non-fusion nanotube surfaced transpedicular screw fixation study as well as our swine titanium 3D-micron scaffold pin study, confirming the advantages of the nano titanium surface technology and the micro-porous titanium scaffold coating technology. In this phase I application, the team proposes to assess clear milestones for safety, efficacy, and approach feasibility of the technology in vitro and in vivo. If phase I is successful the team will propose a separate phase II application assessing the durability of stabilization achieved with the novel implant technology and use a novel animal model to assess the reduction in the severe and costly complications of non-fusion/pseudoarthrosis. Importantly, there are no formally FDA reviewed and cleared nano technology labeled implants in the orthopedic market today. This proposed study will be the first commercially oriented translational research in spinal field which will answer important questions about nanotechnology enhanced implants and help these promising technologies to be reviewed by regulators, granted legitimate nanotechnology oriented labels and used in products that benefit society.
