I-Factor Bone Graft vs autograft in anterior cervical discectomy and fusion: 2-year follow-up of the randomized single-blinded food and drug administration investigational device exemption study

Paul M. Arnold, Rick C. Sasso, Michael E. Janssen, Michael G. Fehlings, Robert F. Heary, Alexander R. Vaccaro, Branko Kopjar

Research output: Contribution to journalArticle

Abstract

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. 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. Objective: To report 2-yr follow-up. Methods: 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. Results: At 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor and autograft subjects, respectively (P = .2513), and neurological success rate was 94.87% (i-Factor) and 93.79% (autograft; P = .7869). Neck Disability Index improved 28.30 (i-Factor) and 26.95 (autograft; P = .1448); Visual Analog Scale arm pain improved 5.43 (i-Factor) and 4.97 (autograft) (p = .2763); Visual Analog Scale neck pain improved 4.78 (i-Factor) and 4.41 (autograft; P = .1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor) and 10.18 (autograft; P=.4507), and SF36v2 Mental Component Score improved 7.88 (i-FactorTM) and 7.53 (autograft; P = .9872). The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of reoperations) was greater in i-Factor subjects compared to autograft subjects (69.83% and 56.35%, respectively, P=.0302). Twelve (7.45%) i-Factor subjects and 16 (10.53%) autograft subjects underwent re-operation (P = .3411). There were no allergic reactions associated with i-Factor. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)377-384
Number of pages8
JournalClinical Neurosurgery
Volume83
Issue number3
DOIs
StatePublished - Jan 1 2018
Externally publishedYes

Keywords

  • ACDF
  • Autograft
  • I-Factor bone graft
  • P-15 synthetic collagen fragment

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

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