i-Factor™ 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

319 patients with single-level cervical disc disease and scheduled for anterior cervical discectomy and fusion were randomized to the surgery completed with either an allograft (i-Factor™ Peptide Enhanced Bone Graft; Cerapedics Inc.) or local bone autograft. Patients were assessed over 1- and 2-year follow-up for rate of fusion success, a composite endpoint of overall success, clinical scores, and incidence of adverse events. Rate of fusion success was similar between the groups after 12 and 24 months. Rate of overall success (composite endpoint) was significantly higher in the i-Factor group compared to the autograft group at 12 and 24 months. Clinical scores demonstrated no significant differences between groups after 24 months, and most adverse events demonstrated similar rates between groups. Rate of superficial infection, however, was higher among the i-Factor group.