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.
Public Health Relevance Statement: Public Health Relevance: There were an estimated 614,000 instrumented spinal fusion procedures between 2011 and 2012 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 0% to 60% 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 $28,069 in Medicare patients. If one assumes 10% of all patients require re-operation for pseudoarthrosis, the estimated annual cost is $1.7 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 3D 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 "fast fusion' while preserving PEEK's desirable modulus and imaging for IFDs.
Project Terms: 3-Dimensional; Address; Adsorption; Animal Model; Biomechanics; bone; Calcium; Clinical; cost; Data; Deposition; Development; Devices; Diabetes Mellitus; economic cost; Exhibits; Failure (biologic function); Family suidae; Fibronectins; Generations; Grant; Growth; high risk; Human; Image; Implant; implant attachment; In Vitro; in vivo; Infection; innovative technologies; instrument; Label; Malignant Neoplasms; Marketing; Mechanics; Medicare; meetings; member; Modeling; nano; nanoparticulate; Nanotechnology; Nanotubes; novel; operation; Orthopedics; Osseointegration; Osteoblasts; Osteogenesis; Osteopenia; Outcome; Pain; Patients; Phase; phase 1 study; Prevention; Procedures; programs; Pseudarthrosis; public health relevance; Repeat Surgery; Research Personnel; Safety; sample fixation; scaffold; Shear Strength; Societies; Speed (motion); Spinal; Spinal Fusion; Structure; success; Surface; Surface Properties; Technology; Testing; Time; Titania; Titanium; titanium dioxide; Translational Research; United States; Vertebral column; Vitronectin; Work
