Efficacy of i-Factor Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion

(NDI), and Neurological Success endpoints, and similar adverse Study Design. A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial. Objective. The objective of this study was to investigate efficacy and safety of i-Factor Bone Graft (i-Factor) compared with local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. Summary of Background Data. i-Factor is a composite bone substitute material consisting of the P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier. P-15 has demonstrated bone healing efficacy in dental, orthopedic, and nonhuman applications. Methods. Patients randomly received either autograft (N1⁄4154) or i-Factor (N1⁄4165) in a cortical ring allograft. Study success was defined as noninferiority in fusion, Neck Disability Index