Development of an Osteoinductive Spinal Fusion Implant for Enhanced Fusion Rates

DESCRIPTION provided by applicant The objective of this Phase I STTR research is to develop and test osteoinductive lumbar spinal fusion implant prototypes made using materials technology developments discovered by the PI at the University of Kansas In preliminary work lower impedance piezoelectric composite materials that generate power for direct current DC electrical stimulation applications were manufactured and electromechanically characterized In an osteoinductive spinal fusion implant design an insulated piezoelectric composite acts as a power generator to supply negative DC electrical stimulation to a Titanium electrode that is mounted on the surface of the implant Evoke Medical will build on this work and implant design concept to develop and commercialize osteoinductive piezoelectric spinal fusion implants In lumbar spine fusion the success rate reported in published studies ranges from approximately This disparity is primarily due to the high number of difficult to fuse patients e g smokers diabetics DC electrical stimulation has been shown to help increase success rates in the difficult to fuse population and accelerate the rate of bone healing in all patients Preliminay experimental materials research results and pilot large animal studies using a piezoelectric composite spinal fusion implant showed that it could generate faster and better healing in spine fusion While preliminary studies show great promise the current methods of manufacturing this implant are not cost effective it is imperative that Evoke Medical move forward with Randamp D focused on improving the reliability and quality of the manufacturing methods and proving that an actual implant design can withstand mechanical loading Without improved manufacturing methods this potentially disruptive technology has little hope for commercial success In this Phase I STTR we will perform research to develop new methods of making piezoelectric composites that have sufficient mechanical and electromechanical properties and are cost effective to manufacture In Specific Aim we will establish reliable and cost effective methods of manufacturing stacked layered piezoelectric composite inserts In Specific Aim we will prove that piezoelectric composite inserts can produce sufficient power at body loading conditions while maintaining satisfactory mechanical strength In Specific Aim we will prove that the piezoelectric spinal interbody implant has satisfactory electromechanical and mechanical properties for use as DC current generating spinal fusion implants The results of this work will yield knowledge about manufacturing of stacked layer structured composites mechanical properties of those composites and the suitability of the materials for use in implants and will set the stage for Phase II work in further translation of the implant design concept PUBLIC HEALTH RELEVANCE Back pain is one of the most common causes for physician visits in the USA with of all people experiencing severe back pain at some time Spinal fusion surgery is often used to alleviate pain and reestablish stability for the most severe cases Currently over fusion surgeries are performed each year in the US and growing at a rate of over per year The success rate of spinal fusion ranges from approximately with poor healing in the difficult to fuse patients e g smokers diabetics We are proposing to develop a non pharmacological cost effective way to create spinal fusion implants that will provide bone healing electrical stimulation from a humanandapos s body motion Our spinal fusion implant will give surgeons a way to successfully improve their patient care while simultaneously reducing cost of care and improving patient outcomes