The ROI-C zero-profile anchored spacer for anterior cervical discectomy and fusion: biomechanical profile and clinical outcomes

Abstract

IntroductionAnterior 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.ObjectiveThe 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.MethodsThis 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.ResultsThe 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.ConclusionThe 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.

Long-term clinical and radiological outcomes following anterior cervical discectomy and fusion by zero-profile anchored cage

“…Similar observations have been reported in some studies evaluating the clinical efficacy of ACDF using cages with an integrated fixation system. [ 2 3 5 7 12 13 14 ]…”

“…A dysphagia rate of 2% is low compared to plate-augmented ACDF in the literature. [ 12 ] The results obtained are by the results of a recent meta-analysis showing that zero-profile anchored cages had a lower risk of postoperative dysphagia than cages with anterior plate fixation after ACDF. [ 6 ] Furthermore, although subsidence is one of the major concerns when using cages without plate fixation, the present study reported no case of subsidence in the follow-up.…”

A Comparison of the Bridge-type ROI-C Interbody Fusion Cage System and Titanium Mesh Graft With Titanium Plate Fixation in 2-level Anterior Cervical Discectomy and Fusion With Plating and Cage System: A Retrospective Study

“…In our study, the postoperative cervical cobb angle of the two surgery was signi cantly bigger than the preoperative cervical cobb angle, which indicated that both surgery can correct cervical kyphosis. Therefore, the fusion and biomechanical stability of ROI-C are equal to those of ACDF, and satisfactory surgical results of both surgery have been achieved [13] . The results of this study showed that JOA score and NDI score of both groups were improved, and good operation effect was maintained during the follow-up period, which demonstrated that the two surgery can relieve spinal cord and nerve compression, and improve the quality of life of patients.…”

A rare case report of laryngopharyngeal polyp formation following anterior cervical discectomy and fusion (ACDF)

“…The incidence of pharyngoesophageal perforation varies between 0.25 and 1.49% [14]. Other complications of soft-tissue injury [8], nerve injury, loss of fixation [9], degeneration of adjacent segments [10], screw plate migration and pullout, and pharyngeal perforation [12] have been documented.…”

“…The use of plates in ACDF has shown improved clinical outcomes, fusion rates, stability and prevention of graft dislodgement as well as the restoration of the cervical physiological curvature [ 7 ]. Despite the relative safety and efficacy of ACDF, many complications such as soft-tissue injury [ 8 ], loss of fixation [ 9 ], degeneration of adjacent segments [ 10 ], dysphagia [ 11 ] and pharyngeal perforation [ 12 ] have been reported.…”