Back pain is one of the leading reasons for physician visits in the United States and in many cases requires surgical intervention. In the United States, there are over 500,000 spinal fusion surgeries every year, and the frequency of these surgeries is projected to grow 6% per year. The gold standard for bone graft in spinal fusion is autograft from the iliac crest;however, the use of autograft presents multiple challenges including donor site morbidity, blood loss, limited availability, prolonged operating times, and pseudarthrosis due to a slow rate of fusion. As a result, there is a large effort to develop bone graft substitutes or extenders that can not only reduce or replace the need for harvest of autogenous bone but also accelerate the rate of fusion (arthrodesis). Ceramic bone graft substitutes provide osteoconductive and bioresorbable bone graft substitutes but have shown poor results when used as stand-alone treatments. Bone marrow aspirate contains osteoinductive factors, but the current carriers are not adequate for the retention and release of these osteoinductive factors over a prolonged period of time. Therefore, there is an unmet clinical need in spinal fusion surgery for a safe, cost-effective bone graft substitute that can maintain a sustained dose of osteoinductive factors throughout the early stages of the healing process. We have developed a bone graft substitute that can capture and retain osteoinductive growth factors and propose to test its ability to improve the fusion rate in spinal fusion surgery.
Spinal fusion surgery is an effective treatment for back pain but carries multiple risks. We have developed a medical device that can improve the formation of new bone and reduce the risks found with other products. We propose to test our product in a model of spinal fusion.