A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial.
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.
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.
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.
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).
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
∗University of Kansas Medical Center, Kansas City, KS
†Indiana Spine Group, Carmel, IN
‡Center for Spine Disorders, Thornton, CO
§University of Toronto Spine Program and Toronto Western Hospital, Toronto, Ontario, Canada
¶Rothman Institute at Jefferson, Philadelphia, PA
||Rutgers-New Jersey Medical School, Newark, NJ
∗∗Kennedy-White Orthopaedic Center, Sarasota, FL
††Montreal Neurological Institute, Montreal, Quebec, Canada
‡‡Cleveland Clinic, Cleveland, OH
§§University of Washington, Seattle, WA.
Address correspondence and reprint requests to Paul M. Arnold, MD, University of Kansas Medical Center, Department of Neurosurgery, Mail Stop 3021, 3901 Rainbow Blvd., Kansas City, KS 66160; E-mail: email@example.com
Received 1 September, 2015
Revised 20 October, 2015
Accepted 15 December, 2015
The device(s)/drug(s) that is/are the subject of this manuscript is/are being evaluated as part of an ongoing FDA-approved investigational protocol (IDE) or corresponding national protocol for utilization of i-Factor Bone Graft in the application described in this investigation.
Cerapedics, Inc. provided research funding to investigator sites to conduct this Food and Drug Administration (FDA) Investigational Device Exemption trial, including the research departments of the authors of this manuscript. No funding was received for other purposes.
Relevant financial activities outside the submitted work: grants, expert testimony, stocks, employment.