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 i-FACTOR 2-Year follow up IDE study results have been published in the peer-reviewed journal Neurosurgery.
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.
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).