The pinnacle of scientific evidence is the Level I study. i-FACTOR™ Bone Graft is one of a small group of bone grafting technologies that is supported by Level I evidence.
i-FACTOR Bone Graft was evaluated in a 319-patient, prospective, randomized, controlled, multi-center clinical trial assessing its safety and efficacy compared to standard-of-care (autograft). Patients underwent anterior cervical discectomy and fusion (ACDF) and received either i-FACTOR Bone Graft or local autograft in a cortical allograft ring implanted into the target vertebral space prior to placement of the screw/plate fixation construct. The results of this study have been published in the peer-reviewed journal Spine.
- Primary Endpoints: i-FACTOR Bone Graft met all four pre-specified primary endpoints investigated in this study by demonstrating non-inferiority to autograft relative to fusion rate, improvement in neck disability index and neurological success. Additionally, there was no statistical difference between i-FACTOR Bone Graft and autograft relative to the rate of adverse events.
- Overall Success: An assessment of “overall success”, as judged by success in all primary endpoints, was applied to the data analysis in this investigation. The i-FACTOR Bone Graft group demonstrated 68.75% overall success. The autograft control group demonstrated 56.94% overall success. The overall success was a statistically significant difference favoring the i-FACTOR Putty investigational cohort (p=0.0382).