Ifactor member2/20/2023 ![]() In addition, different physical and chemical properties of various ceramics further contribute to the limited evidence. The major obstacle in published literature is small sample size resulting in low evidence and a potential for bias. Ceramics have been present in the spine fusion arena for several decades however, their use has been limited. Recently, a synthetic 15-amino acid polypeptide bound to an anorganic bone material which mimics the cell-binding domain of type-I collagen opened a possibility for osteogenic and osteoinductive roles of this hybrid graft material. This change is based on chemical reaction and various chemical elements present in the bioactive ceramics. Core characteristic of bioactive synthetics is that they undergo change to simulate a beneficial response within the bone. In addition, effort has been placed on the development of bioactive synthetics. In most recent years, focus has been shifted to the use of ceramics in minimally invasive surgeries or implementation of nanostructured surface modification features to promote osteoinductive properties. To provide information on characteristics and use of various ceramics in spine fusion and future directions. It was concluded that rational, evidence-based design of peptide-enhanced bone graft substitutes offers a pathway to clinical maturity in this highly promising field. Peptide choice was found to be critical, but even within recognised families of biologically active peptides, the configurations that appeared to most closely mimic the biological molecules involved in natural bone healing processes were most potent. It was determined that covalent attachment may reduce the known risks associated with growth factor-loaded bone graft substitutes, providing a predictable tissue response and greater clinical efficacy. This review considers the design of peptide-enhanced bone graft substitutes, and how peptide selection and attachment method determine clinical efficacy. The use of smaller, active peptides has the potential to overcome these problems and provide a cost-effective, safe route for the manufacture of enhanced bone graft substitutes. ![]() The clinical use of growth factors has though been associated with complications, some serious. The inclusion of biofunctional molecules with synthetic bone graft substitutes has the potential to enhance tissue regeneration during treatment of traumatic bone injuries. i-Factor and autograft groups demonstrated significant postsurgical improvement and high fusion rates. ![]() I-Factor has met all four FDA mandated noninferiority success criteria and has demonstrated safety and efficacy in single-level ACDF for cervical radiculopathy. A high proportion of patients reported good or excellent Odom outcomes (81.4% in both groups). Improvements in VAS pain and SF-36v2 scores were clinically relevant and similar between the groups. Overall success rate consisting of fusion, NDI, Neurological Success and Safety Success was higher in i-Factor subjects than in autograft subjects (68.75% and 56.94%, respectively, P = 0.0382). There was no difference in the rate of adverse events (83.64% and 82.47% in the i-Factor and autograft groups, respectively, P = 0.8814). Study success was defined as noninferiority in fusion, Neck Disability Index (NDI), and Neurological Success endpoints, and similar adverse events profile at 12 months.Īt 12 months (follow-up rate 87%), both i-Factor and autograft subjects demonstrated a high fusion rate (88.97% and 85.82%, respectively, noninferiority P = 0.0004), significant improvements in NDI (28.75 and 27.40, respectively, noninferiority P < 0.0001), and high Neurological Success rate (93.71% and 93.01%, respectively, noninferiority P < 0.0001). Patients randomly received either autograft (N = 154) or i-Factor (N = 165) in a cortical ring allograft. ![]() P-15 has demonstrated bone healing efficacy in dental, orthopedic, and nonhuman applications. I-Factor is a composite bone substitute material consisting of the P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier. The objective of this study was to investigate efficacy and safety of i-Factor Bone Graft (i-Factor) compared with local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial. ![]()
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