Efficacy of i-Factor Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion: Results of the Prospective, Randomized, Single-blinded Food and Drug Administration Investigational Device Exemption Study

Spine (Phila Pa 1976). 2016 Jul 1;41(13):1075-83. doi: 10.1097/BRS.0000000000001466.

Abstract

Study design: A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial.

Objective: 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.

Summary of background data: 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. P-15 has demonstrated bone healing efficacy in dental, orthopedic, and nonhuman applications.

Methods: Patients randomly received either autograft (N = 154) or i-Factor (N = 165) in a cortical ring allograft. Study success was defined as noninferiority in fusion, Neck Disability Index (NDI), and Neurological Success endpoints, and similar adverse events profile at 12 months.

Results: At 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). 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). 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). Improvements in VAS pain and SF-36v2 scores were clinically relevant and similar between the groups. A high proportion of patients reported good or excellent Odom outcomes (81.4% in both groups).

Conclusion: i-Factor has met all four FDA mandated noninferiority success criteria and has demonstrated safety and efficacy in single-level ACDF for cervical radiculopathy. i-Factor and autograft groups demonstrated significant postsurgical improvement and high fusion rates.

Level of evidence: 1.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Bone Transplantation / methods
  • Bone Transplantation / standards*
  • Cervical Vertebrae / surgery*
  • Device Approval*
  • Diskectomy / methods
  • Diskectomy / standards*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Radiculopathy / diagnosis
  • Radiculopathy / epidemiology
  • Radiculopathy / surgery*
  • Single-Blind Method
  • Spinal Fusion / methods
  • Spinal Fusion / standards*
  • Transplantation, Autologous / methods
  • Transplantation, Autologous / standards
  • Treatment Outcome
  • United States / epidemiology
  • United States Food and Drug Administration