i-Factor (TM) Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study

摘要

BACKGROUND: i-Factor (TM) Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor (TM) compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. OBJECTIVE: To report 2-yr follow-up.