摘要： 目的 对比分析零切迹自锁式椎间融合系统（ROI-C）与传统融合器联合钛板内固定技术在颈椎前路椎间盘切除椎间融合术中的有效性和安全性。方法 纳入2017年3月至2019年3月在天津市人民医院行颈椎前路椎间盘切除椎间融合术的116例颈椎退行性病变患者，术中辅助应用ROI-C（ROI-C组，60例）或传统融合器联合钛板内固定（钛板组，56例），根据颈椎X线和CT扫描、日本骨科协会评分（JOA）、颈椎功能障碍指数（NDI）和Bazaz吞咽困难分级，对比分析手术前后颈椎生理曲度和椎间隙高度，评价术后1、3、6和12个月时神经功能和日常生活质量恢复程度、吞咽困难发生率，术后12个月行影像学检查观察融合器沉降、假关节形成等融合失败现象和相邻椎体节段退行性变，以及呼吸道、食管损伤或食管瘘，脑脊液漏，内固定排异，伤口感染或术后血肿等并发症。结果 与钛板组相比，ROI-C组无论单节段或双节段病变患者手术时间缩短（t=5.619，P=0.001； t=3.110，P=0.002）、术中出血量减少（t=7.448，P=0.001； t=5.946，P=0.001），术后颈椎生理曲度增大（F=82.424，P=0.024）、椎间隙高度增高（F=43.427，P=0.021），JOA评分增加（F=16.024，P=0.016）、NDI指数降低（F=21.439，P=0.024）；两组患者手术前后颈椎生理曲度（F=70.247，P=0.000）和椎间隙高度（F=35.312，P=0.000）、JOA评分（F=13.420，P=0.000）和NDI指数（F=19.523，P=0.000）差异亦有统计学意义，术后1、3、6和12个月随访时颈椎生理曲度（均P=0.001）和椎间隙高度（均P=0.001）测量数据均高于术前，JOA评分高于术前（均P=0.001），而NDI指数低于术前（均P=0.001）。两组患者术后1周吞咽困难发生率差异无统计学意义［48.21%（27/56）对33.33%（20/60）； χ²=2.661，P=0.103］，术后12个月钛板组吞咽困难发生率高于ROI-C组［16.07%（9/56）对0（0/60）； χ²=6.779，P=0.009］。两组患者植骨融合良好，无融合器沉降、假关节形成等融合失败现象，以及呼吸道、食管损伤或食管瘘，内固定排异，切口感染等手术相关并发症；ROI-C组有1例单节段手术患者术中发生脑脊液漏，两组各有1例双节段手术患者术后发生血肿和上位相邻椎体节段退行性变。结论 采用ROI-C行颈椎前路椎间盘切除椎间融合术疗效良好且安全可靠，适用于单节段或连续双节段病变的颈椎退行性病变的治疗。

关键词: 颈椎, 椎间盘切除术, 脊柱融合术, 手术后并发症

Abstract: Objective Comparative analysis of the efficacy and safety of zero - notch self - locking interbody fusion system (ROI - C) and traditional cage combined with titanium plate internal fixation technology in the anterior cervical discectomy and fusion (ACDF). Methods A total of 116 patients with cervical degenerative diseases who underwent ACDF in Tianjin Union Medical Center from January 2014 to December 2016 were included, of which 60 patients underwent the ROI-C (ROI-C group) and 56 patients underwent traditional cage combined with titanium plate internal fixation (titanium plate group). According to cervical vertebral X -ray and CT, Japanese Orthopaedic Association Scores (JOA), Neck Disability Index (NDI) and Bazaz dysphagia classification, the physiological curvature and intervertebral space height of cervical vertebal before and after surgery were compared and analyzed, and the degree of neurology function and quality of daily life recovery, and incidence of dysphagia at 1, 3, 6, and 12 months after surgery were evaluated. The imaging examination were set at 12 months after surgery to evaluate the fusion failure phenomenon such as cage subsidence, pseudoarthrosis, and the degeneration of adjacent vertebral segments, as well as respiratory, esophageal injury or esophageal fistula, cerebrospinal fluid (CBF) leakage, internal fixation rejection, wound infection and postoperative hematoma. Results Compared with titanium plate group, patients with single-segment or double-segment lesions in ROI-C group showed shorter operation time (t = 5.619,P = 0.001; t = 3.110,P = 0.002), and decreased intraoperative blood loss (t = 7.448,P = 0.001; t = 5.946,P = 0.001), increased postoperative cervical physiological curvature (F = 82.424,P = 0.024), increased intervertebral space height (F = 43.427,P = 0.021), increased JOA score (F = 16.024,P = 0.016) and decreased NDI index (F = 21.439,P = 0.024). The difference between the physiological curvature of cervical spine (F = 70.247,P = 0.000), intervertebral space height (F = 35.312,P = 0.000), JOA score (F = 13.420,P = 0.000) and NDI index (F = 19.523,P = 0.000) before and after surgery in 2 groups was statistically significant at 1, 3, 6 and 12 months of follow-up, the measured data of cervical physiological curvature (P = 0.001, for all) and intervertebral space height (P = 0.001, for all) were higher than those before surgery, the JOA score increased (P = 0.001, for all) and the NDI index decreased (P = 0.001, for all). There was no significant difference in the incidence of dysphagia one week after surgery [48.21% (27/56) vs. 33.33% (20/ 60); χ² = 2.661,P = 0.103]. The incidence of dysphagia in the titanium plate group was higher than that in the ROI-C group at 12 months after surgery [16.07% (9/56) vs. 0 (0/60); χ² = 6.779,P = 0.009]. In addition, no incision infection, respiratory tract, oesophagal injury, oesophagal fistula, internal fixation rejection and other related complications occurred during the 12 - month follow - up period. One case of CBF leakage during single - segment ACDF surgery with ROI - C. Hematoma and upper adjacent vertebral segment degeneration occurred in one patient in each group. Conclusions ACDF surgery with ROI - C has good efficacy and safety, it is suitable for treating patients with cervical degenerative diseases with single-segment or continuous double-segment lesions.

Key words: Cervical vertebrae, Diskectomy, Spinal fusion, Postoperative complications