![ifactor bone graft ifactor bone graft](https://ryortho.com/wp-content/uploads/2015/06/NoFDA_iFactorBoneGraft_WEB.jpg)
Use of i-Factor™ in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery. Bone grafts can be harvested from the patient (autograft), a cadaver (allograft), or they can be synthetic. There were no allergic reactions associated with i-Factor™. Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation ( P =. The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P =. 4507), and SF36v2 Mental Component Score improved 7.88 (i-Factor TM) and 7.53 (autograft P =. 1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft P =. 2763) Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft P =. 1448) Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p =. Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft P =. 2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft P =. RESULTSĪt 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively ( P =. Subjects randomly received either autograft (n = 154) or i-Factor™ (n = 165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes. Next-generation, advanced synthetic bone grafts are being increasingly favored by surgeons because they play an active role in the bone healing process and can improve patient outcomes.
#Ifactor bone graft trial
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). i-FACTOR Bone Graft is one of a small group of bone grafting technologies that is supported by Level I evidence. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. The pinnacle of scientific evidence is the Level I study. Cerapedics is now actively involved in introducing the i-FACTOR Bone Graft technology platform into the rapidly expanding market for osteobiologic products.I-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. Since approval, ABM/P-15 has been used in an estimated 500,000 procedures.įrom these roots, Cerapedics has reformulated the (ABM/P-15) product and branded it i-FACTOR Peptide Enhanced Bone Graft to capture the unique “attachment factor” mechanism of action. Results of logistic regression (with generalised estimating equations) predicting likelihood of bone healing with use of i-FACTOR. Background: i-Factor Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier.
![ifactor bone graft ifactor bone graft](https://www.archwayoralsurgery.com/wp-content/uploads/files/2019/102ed1_edf3519e41d046f28830ff7fc58f123d-mv2_d_2028_1336_s_2-300x197.png)
It remains the only dental bone graft substitute with FDA approved claims of superiority over demineralized bone matrix (DBM) allograft and alloplasts. The product received PMA approval in 1999 based on the results of two prospective multi-center investigations. The first P-15 enhanced bone graft substitute was developed for use in the oral cavity by CeraMed Dental – the precursor to Cerapedics – under the leadership of Andrew J. 190, 192 This bone graft combination of ABM and P-15, also known as i-Factor, is claimed to facilitate bone formation. In November 2015 Cerapedics received FDA approval for the use of i-FACTOR bone graft in ACDF procedures in patients with degenerative cervical disc disease.
![ifactor bone graft ifactor bone graft](https://omegadentists.com/wp-content/uploads/2017/11/Adobe-Spark-23-1000x563.jpg)
This novel (ABM/P-15) combination acts as an attachment factor for osteogenic cells. ABM consists of smooth, porous particles of pure deproteinated hydroxyapatite. iFACTOR bone graft is based on synthetic small peptide technology and supports bone growth through cell attachment and activation. Our lead technology platform (i-FACTOR Peptide Enhanced Bone Graft) is the only biologic bone graft that uses a unique small peptide attachment factor (P-15) bound to anorganic bone mineral (ABM).