Unmet NeedSpinal fusion is the welding together of adjacent vertebrae. Each year, more than 400,000 Americans undergo spinal fusion to treat conditions like neck and back pain, spinal instability, radiculopathy, and myelopathy. These surgeries require many items, such as spinal rods, screws, and cages. In addition, they require a bone graft to fill into the space that will be fused. Currently, the gold standard bone graft is iliac crest autograft. However, even with the use of this bone graft, the bones fail to weld together in some 30% of cases. When this happens, called pseudoarthrosis, patients are often left with significant pain and disability. Existing bone graft substitutes fail to improve on the results of iliac crest autograft. Consequently, there remains an outstanding need for more efficacious bone graft materials.
Technology OverviewUtilizing tissue engineering strategies, the inventors have developed a bone graft substitute material designed to eliminate pseudoarthrosis in spinal fusion, while simultaneously obviating the need for iliac crest autograft. The inventors’ bone graft substitute combines inorganic (e.g., calcium phosphate) and organic (e.g., collagen) components to form a biomimetic scaffold. This material is further modified and loaded with growth factors, which are slowly released to stimulate vasculature and bone formation. The inventors’ bone graft substitute was specifically designed for spinal fusion, though it may also be used in other applications of bone grafting. Preliminary results in animal models have shown improved fusion rates to currently employed bone graft substitute materials.
Stage of DevelopmentThe inventors have developed a novel bone graft substitute material that is currently being tested in animal models of spinal fusion.