Cells have a naturally high affinity for P-15, and once attached, are activated to begin the production of essential growth factors. This combination provides a proven osteoconductive scaffold with an abundance of P-15 attachment sites, allowing for increased cell binding at the fusion site. i-FACTOR Bone Graft combines a synthetic version of this peptide, known as P-15, with a hydroxyapatite, anorganic bone mineral (ABM). This protein segment is responsible for the attachment and proliferation of osteogenic cells that produce bone. Unlike other biologic bone grafts, i-FACTOR Bone Graft has a unique and powerful mechanism of action that is based upon the biological activity of a 15-amino acid peptide sequence naturally found in human Type I collagen. These potent exogenous growth factors stimulate stem cells to differentiate down the osteogenic lineage, but the enhanced fusion potential comes with high costs and the risk of increased complication rates. ![]() Biologic bone grafts are often classified as drug/device combinations, of which recombinant human bone morphogenetic proteins (rhBMPs) are the primary example. In recent years, a number of products have been introduced that incorporate an active component to positively influence the fusion process. Whether natural (allograft, simple demineralised bone matrix ) or synthetic (hydroxyapatite, calcium phosphate), the majority of materials are simple osteoconductive substitutes offering a scaffold for fusion that is gradually resorbed over time, but does not actively promote bone growth. This has stimulated the search for substitute biomaterials that offer an equivalent level of performance. However, its use is often associated with donor site morbidity, and does not offer reliable levels of quality or volume. i-FACTOR Bone Graft offers a powerful and safe mechanism of action, proven by the highest quality of evidence which is demanded by surgeons, administrators and payers to support therapeutic and coverage decisions.Īutograft bone has long been considered the gold standard for spinal fusion as it has osteoconductive, osteoinductive and osteogenic properties. Amongst the many bone graft substitutes available, i-FACTOR Bone Graft (Cerapedics, Inc.) is the only synthetic bone graft to demonstrate superiority to autograft according to independent radiographic evidence and patient-reported outcomes from a prospective, randomised Level I clinical study. Today’s market is flooded with a variety of different products, all aiming to replicate the performance and safety of autograft bone which clinicians still regard as the “gold standard”. "This study demonstrates that treatment with i-FACTOR bone graft results in similar and on some metrics superior outcomes compared to local autograft bone.This article is sponsored by Cerapedics, Inc.Ī FAST, RELIABLE AND PROVEN ALTERNATIVE TO AUTOGRAFT i-FACTOR peptide-enhanced bone graft is challenging the gold standard in bone grafting and revolutionising expectations for spinal fusion.īone graft substitutes are used extensively in spinal surgery as a means to encourage bone healing and fusion. Arnold, MD, professor of neurosurgery at University of Kansas Medical Center. "Until now, alternatives to autograft bone for use in ACDF procedures had not been evaluated in rigorous randomized, controlled studies," said co-investigator and lead author of the Spine paper Paul M. The technology has FDA approval for use in ACDF procedures for patients with degenerative cervical disc disease. The i-FACTOR bone graft is based on synthetic small peptide technology and sports bone growth through cell attachment and activation. The difference was statistically significant for superiority.ĥ. The overall success rate for the four primary outcomes showed 69 percent success factor for the i-FACTOR bone graft, compared with 57 percent in the autograft group. There wasn't any difference in the adverse event rates for both groups.Ĥ. ![]() There was high neurological success rate for i-FACTOR and the control group - 93 percent.ģ. The i-FACTOR bone graft reported 88.9 percent fusion rate, compared with the control group with 85.8 percent fusion rate.Ģ. There were 154 patients who underwent the procedure with bone graft and autograft and 165 with i-FACTOR bone graft. Here are five key notes on the randomized, single-blinded study patients received either autograft or i-FACTOR:ġ. Orthobiologics company Cerapedics reported results from the FDA investigational device exemption clinical trial for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion procedures, published in Spine. 20 cutting-edge spine innovations to know | 2021.Women's + Diversity Leadership Virtual Forum.Clinical Leadership + Pharmacy Virtual Event. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |