Zero-profile anterior cervical ROI-C cage versus traditional fusion cage combined with titanium plate in treatment of two-level cervical spondylotic myelopathy / 中国组织工程研究

ABSTRACT

BACKGROUND: Self-locking self-stabilizing zero-profile cage ROI-C is advanced from the traditional titanium plate fusion cage, but the systematic studies on ROI-C internal fixation system applied in the comprehensive evaluation of two-level cervical spondylotic myelopathy are few. OBJECTIVE: To comprehensively evaluate the clinical efficacy of small-incision anterior cervical self-locking self-stabilizing zero-profile cage ROI-C in the treatment of two-level cervical spondylotic myelopathy. METHODS: Fifty-seven patients with two-level cervical spondylotic myelopathy at the First Affiliated Hospital of Guangdong Pharmaceutical University from September 2016 to March 2018 were selected, including 30 males and 27 females, aged 34-77 years old. Of which, 33 patients underwent small-incision anterior cervical self-locking self-stabilizing zero-profile fusion cage ROI-C implantation (observation group), and another 24 patients received small-incision cervical anterior titanium internal fixation (control group). The JOA score, Neck Disability Index, Odom criteria, Visual Analogue Scale score, dysphagia degree, Cobb angle of cervical lordosis, angle of fusion segment, and disc height and cervical fusion rate were assessed at 2 weeks and 1, 3, 6, and 12 months after surgery. The study was approved by the Ethics Committee of the First Affiliated Hospital of Guangdong Pharmaceutical University. RESULTS AND CONCLUSION: (1) There was no significant difference in the Odoms criteria between two groups (P > 0.05). All 57 patients were followed up for 12 months after surgery. No internal fixation loosening or vertebral structure changes were found. No complications such as loosen and broken of titanium plate occurred. (2) Postoperative JOA score, Neck Disability Index, and Visual Analogue Scale in the two groups were significantly improved compared with those before surgery (P 0.05). (3) The incidence of dysphagia at 2 weeks and 1 month in the observation group was significantly lower than that in the control group (P 0.05). (4) The Cobb angle of cervical lordosis, angle of fusion segment, and disc height were significantly improved in both groups after surgery (P 0.05). (5) The cervical fusion rate at the last follow-up in both groups was > 95%, and the fusion effect was good. There was no significant difference in the fusion rate at different time points between two groups (P > 0.05). (6) These results indicate that the small-incision anterior cervical self-locking self-stabilizing Zero-profile interbody fusion ROI-C and anterior titanium plate internal fixation exert significant effects in the treatment of two-level cervical spondylotic myelopathy. However, ROI-C can reduce the incidence of postoperative dysphagia.