Phase II Amount
$1,227,401
Spinal fusion is the standard treatment for persistent neck and back pain, but the hardware used to stabilize the fusion can harbor or even promote bacteria that lead to persistent, difficult-to-treat infections that are costly and damaging to patient health. Among the available materials for spinal fusion, polyether-ether-ketone (PEEK) cages stand out due to their strength, bio compatibility, and radiolucency, but like other materials, they are susceptible to spinal infections. Silicon nitride (Si3N4) spacers have been used in other spinal applications where their rates of reportable adverse events due to infection are much lower than industry norms, but they are not ideal for stabilizing spinal fusions due to their potential for subsidence and brittle fracture. To address this challenge, SINTX used Phase I SBIR funding to develop and test a 3D-printed Si3N4-PEEK material that incorporates the antimicrobial and osseointegrative properties of Si3N4 with the strength and elasticity of PEEK. In this Phase II SBIR, SINTX proposes to use this material to develop a 3D-printed anti-microbial spinal fusion cage that promotes osseointegration, withstands in vivo loading, and facilitates imaging. The project includes long-term biomechanical performance and in vivo fusion property testing in both normal and contaminated operative scenarios. Successful completion of these activities will position SINTX to prepare a 510(k) premarket notification application for FDA. SINTX anticipates further development and commercialization of a 3D-printedSi3N4-PEEK spinal fusion cage will provide orthopedic surgeons a high-performance fusion device that could greatly reduce the incidence of fusion-associated infections. Aim 1. Minimize potential design and manufacturing hazards by formal design and process risk management analyses in accordance with ISO 14971. Milestone: Completion of the design FMEA and process FMEA per ISO 14971 to minimize risks associated with the novel cervical cages and design freeze. Aim 2. Verify that the finalized 3DP Si3N4-PEEK cervical cage meets the static and fatigue loading requirements of ASTM F2077 and subsidence requirements of ASTM F2267. Milestone: Following the design freeze in Aim 1, demonstrate static and fatigue compression, shear, and torsion strength and subsidence resistance of the finalized 3DP Si3N4-PEEK's porous cage meets or exceeds the guidelines for cervical cages established by ASTM F2077 and ASTM F2267 and benchmarked for many cage manufacturers in the literature. Aim 3. Determine antimicrobial activity (experimental arm) and in vivo biocompatibility and osteointegration (biocompatibility GLP arm) for a 3DP Si3N4-PEEK cervical cage in a caprine model of cervical spinal fusion. Milestone: Final, packaged, and validated implants will pass requirements in ISO 10993.3DP Si3N4-PEEK implants will have biocompatibility, bone in growth, fusion, and resistance to infection comparable to or better than control 3DP PEEK spinal cages.
Public Health Relevance Statement: Project narrative: Up to 12% of spinal fusion surgeries fail due to infection, resulting in substantial personal and financial costs. This study is designed to complete the development of a spinal fusion device that includes a new composite of PEEK, a common material used to stabilize spinal fusions, plus silicon nitride, a medical implant material with excellent antibacterial and bone integration properties. Commercialization of an antimicrobial spinal fusion device is expected to substantially reduce the incidence of spinal fusion failure due to infection, potentially saving hundreds of millions of dollars annually and improving patient outcomes and quality of life.
Project Terms: Animals; Back Pain; Back Ache; Backache; Bacteria; Biomechanics; biomechanical; bone; Neck Pain; Cervical Pain; Cervicalgia; Cervicalgias; Cervicodynia; Cervicodynias; Neck Ache; Neckache; Financial cost; Elasticity; Ethers; Fatigue; Lack of Energy; Foundations; Fracture; bone fracture; Freezing; Growth; Generalized Growth; Tissue Growth; ontogeny; Health; Recording of previous events; History; histories; Human; Modern Man; Incidence; Industry; Infection; instrumentation; Ketones; Literature; Marketing; Medical Device Designs; Orthopedics; Orthopedic; Orthopedic Surgical Profession; Patients; Quality of life; QOL; Risk Management; Spinal Fusion; Spondylosyndeses; Vertebral column; Spinal Column; Spine; backbone; Testing; silicon nitride; Si3N4; Osseointegration; Porosity; Guidelines; improved; Cervical; Phase; Susceptibility; Predisposition; Failure; Funding; Antibacterial Agents; anti-bacterial; antibacterial; Anti-Bacterial Agents; Congenital failure of fusion; fusion failure; Consensus; Mechanics; mechanic; mechanical; Notification; implant material; Resistance to infection; infection resistance; Spinal; Benchmarking; Best Practice Analysis; benchmark; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Surgeon; biomaterial compatibility; biocompatibility; Performance; hazard; novel; Devices; Cervical spine; Cervical Vertebrae; Positioning Attribute; Position; Modeling; Property; Adverse event; Adverse Experience; Documentation; Manufacturer; Torsion; preventing; prevent; Address; Goat; Caprine Species; Goats Mammals; Animal Testing; International; in vivo; research clinical testing; Clinical Evaluation; Clinical Testing; clinical test; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; patient oriented outcomes; Perioperative; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Process; Development; developmental; Image; imaging; Pathway interactions; pathway; cost; medical implant; post-market; designing; design; resistant; Resistance; anti-microbial; antimicrobial; Implant; commercialization; standard treatment; standard care; risk minimization; Sterilization; arm; 3-D print; 3-D printer; 3D printer; 3D printing; three dimensional printing; 3D Print; experimental arm; manufacture
