Durable Biomechanical Stabilization of Spinal Fusion Segments Despite Pseudoarthrosis Using Spinal Implants with Nano and Micron Porous Hierarchical Structures in a Novel Non-Union Model

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 D 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 PUBLIC HEALTH RELEVANCE There were an estimated instrumented spinal fusion procedures between and in the United States alone Spinal pseudoarthrosis leads to a significant chance of reoperation and a poor long term outcome including severe complications such as recurring debilitating pain segmental instability hardware loosening hardware failure and infection Spinal fusion yields pseudoarthrosis rates from to which are highly patient related Notably higher risk patients include those with multiple fusion levels osteopenia diabetes cancer and previously failed fusions The toll in human suffering of the complications of pseudoarthrosis is considerable and the economic cost is quantifiable with an estimated $ in Medicare patients If one assumes of all patients require re operation for pseudoarthrosis the estimated annual cost is $ billion annually in the United States alone To address the above serious clinical and societal issues created by the complications of pseudoarthrosis the team proposes to evaluate and commercialize an innovative technology platform capable for the first time of stabilizing a spine segment without fusion Specifically the team proposes to combine our nanotube surface technology with our D micron porous titanium scaffold PEEK implant technology to create a rapid stabilizing interbody fusion device The implant is expected to provide faster and stronger biologic fixation that create in effect a andquot fast fusionandapos while preserving PEEKandapos s desirable modulus and imaging for IFDs