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. Randomised double-blind clinical trial of i-FACTOR Peptide Enhanced Bone Graft versus Bone Bank Allograft in non-instrumented lumbar fusion surgery. 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-FactorTM) 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 =.
IFACTOR ALLOGRAFT PLUS
those treated with allograft plus local bone. 1448) Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p =. Demineralized bone matrix (DBM) is a type of allograft. Results from a clinical trial evaluating i-FACTOR® Peptide Enhanced Bone Graft in non-instrumented lumbar fusion demonstrate that elderly patients treated with i-FACTOR bone graft plus local bone had a statistically significantly higher fusion rate vs. 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 =. 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.Īt 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively (P =. 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. 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.
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