In Vivo Performance of a Novel Hyper-Crosslinked Carbohydrate Polymer Bone Graft Substitute for Spinal Fusion.

Abstract

Bone graft materials are essential for achieving arthrodesis after spine surgery. Safe bone graft products, with osteoinductive, osteoconductive properties and the ability to monitor fusion in real-time, are highly desirable. A novel hyper-crosslinked carbohydrate polymer (HCCP) bone graft substitute was shown to aid in bone regeneration in critical-size defect studies in a rabbit model. These studies further evaluated the in vivo application of HCCP as a bone graft substitute in an ovine model of spinal fusion and a retrospective study in adult human spine surgery patients. Sheep studies demonstrated the safety and efficacy of HCCP with no evidence of adverse histopathology over 6 months of follow-up. In human studies, patients (N = 63) underwent posterolateral fusion with HCCP, with follow-up to assess fusion success. No adverse reaction related to the HCCP bone graft substitute was identified. Fusion success was noted to be non-inferior to other bone graft substitutes. HCCP appears to be a safe bone void filler adjunct for use in spinal fusion surgery for both trauma and degenerative disease. It has a good degradation profile for forming bone with the ability to provide new vasculature and may also function as a scaffold to carry cells, medications, and growth factors. Given the safety profile experienced in our preclinical and clinical studies, future investigation into its efficacy to achieve solid fusion is currently ongoing.