微创ROI-C式椎间融合器在颈椎前路中的临床应用研究

Application Research on Anterior Cervical Cage Instrument of ROI-C in Anterior Cervical Discectomy and Fusion Surgery

目的:评价应用自稳型插片式椎间融合器(Zero notch self stabilizing cervical fusioncage, ROI-C)在颈椎前路患者中的临床疗效和安全性,并进一步找寻其优缺点。方法:回顾性分析自2017年6月至2018年6月在我院诊断为颈椎病并行颈前路椎间盘减压植骨融合内固定手术(Anterior cervical discectomy and fusion,ACDF)的患者,共计84例。根据手术中使用内固定的不同,分为观察组(ROI-C组;48例)和对照组(常规融合器+钢板组;36例)。比较术后3天、1月,及12个月的VAS、JOA及Macnab评分。比较两组患者在手术中的情况(出血量,手术时间,住院时间等)的功能评分;在术后1年时比较两组患者的并发症情况。结果:在术后的各个时间截点的比较中,两组患者在VAS、JOA及Macnab评分中较术前均有显著性改善(P<0.05),但两组间均无显著统计学差异(P>0.05)。两组患者在最后一次(术后1年)的并发症的比较中未见显著性差异(P>0.05)。观察组在手术中各项指标的比较中均显著优于对照组。结论:与传统的常规融合器-钢板ACDF治疗方法相比,自稳型插片式椎间融合器能够达到相似的治疗效果及安全性。但能够有效的减少手术时间及出血量,缩短住院时间,并有效提高患者术后的舒适度,在临床中可以进一步推广。

Objective: To evaluate the clinical efficacy of ROI-C in ACDF and to explore its advantages and disadvantages.Methods: From 2017.06 to 2018.06, 84 cases of patients with Cervical spondylotic myelopathy included in this study, and all of the patients have received Anterior Cervical Discectomy and Fusion were divided into two groups according to different operation ways. 48 patients underwent surgery using ROI-C(experimental group), while 36 patients underwent surgery with Anterior Cervical Locking Plate System(control group). The operation time, bleeding and hospital stay were compared between the two groups, and using VAS score and JOA score to evaluate the clinical efficacy, and make a record of surgical complications, and SPSS 19.0 is used for statistical analysis.Results: There was no significant difference in VAS, JOA and Macnab score between the two groups in 3 days, 6 months and 12 months after operation(P > 0.05) while it has a statistically significant difference compared with preoperative(P < 0.01). Surgeries in both of the two groups were successfully completed, and there were no complications such as nerve injury, hematoma and infection(P > 0.05). There was significant difference in the operation time, operation blood lose and hospital stay time between the two groups. Conclusions:Comparing the traditional system of anterior cervical locking plate in ACDF, using the ROI-C in the treatment of cervical spondylosis has a definite clinical curative effect, however, which can short operation time and the reducing postoperative swallowing discomfort and short hospital stay time, which is worth to promotion and application.