ERC - Small Business: Biological and Biomechanical Assessment of Magnesium as a Possible Bioresorbable Material for Intervertebral Spinal Fusion

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This effort is a collaboration between the Engineering Research Center for Revolutionizing Metallic Biomaterials (RMB) at the North Carolina A&T State University, its partner institutions (the University of Pittsburgh, the University of Cincinnati, Hannover Medical School, industrial, innovator, and state and local government partners) and NC-based ERC small business innovation partner OrthoKinetic Technologies LLC and Southeast TechInventures, Inc., a technology accelerator also located in NC. The ERC was started in 2008. This proposal, specifically addresses the degradable Mg system developed at the ERC-RMB as a possible material for intervertebral spinal fusion application.Intellectual MeritThe purpose of this effort is to transform current medical and surgical treatments by creating "smart" implants for craniofacial, dental, orthopedic, cardiovascular, thoracic and neural interventions. The ERC will develop biodegradable systems that combine novel bioengineered materials based on magnesium with miniature sensor devices that can control the integrity of implants. The ERC will develop biodegradable systems that combine novel bioengineered materials based on magnesium with miniature sensor devices that can control the integrity of implants. Biodegradable systems offer significant therapeutic advantages over implants used today. Such systems will be able to grow and adapt to the human body and eventually dissolve when no longer needed. The first phase of this research is to synthesize magnesium alloys that are biomechanically stable for possible use as a spinal fusion cage. The effort explores the use of alloying elements to increase corrosion resistance, increase toughness, and promote osteointegration. The second phase of this study will provide a comprehensive mechanical assessment of a spinal fusion cage for the lumbar spine using magnesium and its alloys as the bioresorbable materials. The third phase will be corrosion assessment or resorption process analysis. Broader Impact Spinal surgery is often a final alternative to spinal stabilization and relief of pain. Bone graft fusion with accompanying spinal instrumentation systems is a conventional surgical technique used to stabilize the spine. The eventual goal of this bone graft and spinal instrumentation construct is to create a balanced environment where the spinal instrumentation is used to initially function as the load bearing element that immobilizes the fusion segment during the early unstable stages of bone grafting and healing. The U.S. market for spinal implants is estimated to exceed $8 billion by 2016, while the minimally invasive surgical (MIS) spinal implant market is estimated to reach over $3 billion. The education and outreach plans are achieved through the ongoing ERC programs through broad-based outreach programs targeted at elementary and secondary school students, community college students and their teachers, counselors, parents and administrators. These include informal education, parent information sessions. This effort addresses the need for a novel biocompatible biomaterial capable of resorbing and allowing creep substitution by bone during resorption, while maintaining mechanical structural integrity, as an ideal alternative to spinal fusion.