Medical Devices: Evidence and Research (Apr 2017)
The ROI-C zero-profile anchored spacer for anterior cervical discectomy and fusion: biomechanical profile and clinical outcomes
Abstract
Michael N Bucci,1 Dennis Oh,2 R Scott Cowan,3 Reginald J Davis,4 Robert Jackson,5 Dwight S Tyndall,6 Daniel Nehls7 1Piedmont Spine and Neurosurgical Group, PA, Greenville, SC, USA; 2Baystate Medical Center, Springfield, MA, USA; 3New England Orthopedic Surgeons, Inc., Springfield, MA, USA; 4Greater Baltimore Medical Center, Baltimore, MD, USA; 5Orange County Neurosurgical Associates, Laguna Hills, CA, USA; 6Orthopedic Specialists of Northwest Indiana, Munster, IN, USA; 7Franciscan Neurosurgery Associates at St. Joseph Medical Center, Tacoma, WA, USA Introduction: Anterior cervical discectomy and fusion (ACDF) has been the gold standard for treating cervical degenerative disc disease (cDDD). The use of anterior plates in ACDF poses an increased risk of complications such as screw or plate dislodgement, soft tissue injury, esophagus perforation, and dysphagia. The ROI-C™ implant system consists of a zero-profile interbody fusion cage with self-locking plates designed for stand-alone fusion without external plates or screws.Objective: The purpose of this report is to describe the ROI-C™ implant system with VerteBRIDGE™ anchor plates, including indications for use, surgical technique, preclinical testing, and clinical study results. The objectives of the clinical study were to assess fusion status, incidence of dysphagia and other device-related complications, and patient reported outcomes.Methods: This was a retrospective, multicenter cohort study of 110 patients who underwent ACDF with ROI-C at seven study centers. Patient charts and radiographs were reviewed for any complications or device malfunction. The final follow-up was conducted prospectively and included collection of neck disability index, and visual analog scale (VAS) neck and arm pain scores.Results: The mean operation time was 73 minutes, and mean blood loss was 25 mL (range 0–75 mL). Mean follow-up was 20.7 months (range 9.5–42.2). Dysphagia was reported in two patients (1.8%), and 99.1% of patients achieved fusion. One patient had radiographically confirmed pseudarthrosis at 12 months that was asymptomatic and did not require surgery. One patient had subsequent surgery owing to adjacent level degeneration. The mean neck disability index, VAS neck pain, and VAS right and left arm pain scores at final follow-up were 19, 26.5, 12.5, and 15.3, respectively.Conclusion: The ROI-C interbody cage with VerteBRIDGE anchor plates achieved a high rate of fusion, with a low incidence of dysphagia. These patients had similar or better outcomes compared to ACDF with anterior plating reported in peer-reviewed literature. Keywords: ROI-C, zero-profile spacer, ACDF, stand-alone cage, cervical disc degeneration
