Surgeons have many options when choosing to replace or augment autograft in their fusions. These options often vary in form, function, and composition with very few supported by high quality evidence of safety or performance. At Cerapedics, we believe that the best products result from rigorous scientific and clinical research.
Attachment factor for anchorage-dependent cells
Bone is a rigid composite of mineral (hydroxyapatite) and collagen (primarily Type I). The collagen fibers serve to conduct mechanical forces that are crucial to the behavior of bone cells. The relationship between cells and their surrounding three-dimensional network of force conducting native collagen fibers is essential for normal bone physiology, maintenance and repair. In the body, most cells are attached to native collagen by highly specific points of contact. This point of recognition and contact is a fifteen amino acid sequence, which has been replicated in the synthetic peptide P-15.
Cell migration along the collagen network is an anchorage-dependent process known as haptotaxis. Simply put, cell motility is a grab and release mechanism in which the P-15 domains serve as rungs on a ladder. Incorporation of these P-15 peptides into the microstructure of anorganic bone mineral has been shown to facilitate and expedite ingrowth of bone by promoting the immigration of reparative cells from the surrounding tissue. The following is a subset of the in vivo and in vitro evidence supporting the safety and efficacy of P-15.
Superior to autograft in overall success
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 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).