桥形椎间锁定融合器（ROI-C）在颈椎病前路减压融合术中应用的临床研究

Clinical research of double-way connection intervertebral fusion device(ROI-C) for anterior cervical discectomy and fusion

中文关键词:  颈椎病  颈椎前路减压融合术  桥形椎间锁定融合器（ROI-C）  对比研究

英文关键词:Cervical myelopathy  Anterior cervical discectomy and fusion(ACDF)  Double-way connection intervertebral fusion device(ROI-C)  Clinical efficacy

中文摘要:

  【摘要】 目的：对比桥形椎间锁定融合器（ROI-C）或cage联合前路钛板固定治疗颈椎病的疗效，分析ROI-C在颈椎病前路手术应用的临床效果。方法：回顾性分析2011年6月~2013年11月我科采用桥形锁定椎间融合器或cage联合前路钛板内固定治疗颈椎病患者共104例。其中桥形椎间锁定融合器组（A组）患者46例，共89个节段，作为观察组；应用cage联合前路钛板内固定组（B组）患者58例，共106个节段，作为对照组。两组患者术前均行颈椎正侧位X线片、动力位X线片，CT冠矢状重建，MRI检查，术后3d摄片复查，术后3个月、6个月、1年定期随访，行颈椎正侧位及动力位片复查，选择性复查CT及MRI，观察两组患者在手术时间、术中出血量、术后吞咽困难、术前术后JOA评分及改善率、VAS评分、颈椎生理曲度（Cobb角）、椎间高度、融合情况、术中及术后并发症等指标方面有无差异。结果：术后随访3～26个月，平均18个月。A组手术时间（一个节段73.2±8.1min，两个节段127.4±13.4min，三个节段152.7±19.4min）及术中出血量（1个节段62.3±20.2ml，2个节段83.2±32.4ml，3个节段 110.5±54.3ml）均明显低于B组（手术时间：一个节段84.3±7.2min，两个节段147.6±13.1min，三个节段184.1±21.3min；术中出血量：1个节段100.2±22.1ml，2个节段128.3±35.3ml，3个节段190.6±57.2ml），差异有统计学意义（P<0.05）。A组术前、术后JOA评分分别为9.49±0.83分和12.45±1.00分，B组分别为9.21±1.00分和12.04±0.89分，两组术后JOA评分较术前均改善，差异有统计学意义（P<0.05）。A组术前、术后VAS评分分别为2.94±0.56分和1.24±0.44分，B组分别为2.88±0.54分和1.26±0.43分，两组术后VAS评分较术前改善，差异有统计学意义（P<0.05），两组间术前及术后JOA评分及改善率、VAS评分没有统计学差异（P>0.05）。A组术前、术后Cobb角分别为20.35°±7.12°和26.82°±6.13°，B组分别为18.34°±7.32°和25.32°±8.91°，两组术后颈椎生理曲度较术前有明显改善，差异有统计学意义（P<0.05），两组间无统计学差异（P>0.05）。A组术前、术后病变椎间隙高度分别为5.83±1.02mm和8.47±1.83mm，B组分别为5.54±1.82mm和8.03±2.43mm，两组术后病变椎间隙高度较术前有明显改善，差异有统计学意义（P<0.05），两组间无统计学差异（P>0.05）。A组术后吞咽困难发生率为6.52%，46例患者中仅有3例术后出现轻度吞咽困难，且症状在1个月内逐渐缓解；B组术后吞咽困难发生率为34.48%，58例患者中，轻度吞咽困难13例，中度吞咽困难7例。A组术后吞咽困难发生率明显低于B组，差异有统计学意义（P<0.05）。至末次随访时，A组45例融合，融合率为97.8％；B组55例融合，融合率为94.8％；两组间无明显差异（P>0.05）。两组未融合病例，至末次随访时临床症状均较术前改善明显，无相关不适。两组患者均无气管、食管损伤及喉返神经损伤等手术并发症发生。结论：颈椎桥形椎间锁定融合器（ROI-C）能有效地恢复颈椎的生理曲度及椎间高度，可以获得满意的融合率，且手术操作相对简便，手术时间较短，术中出血量较少，周围组织损伤较少，术后吞咽困难发生率低等优点，有望替代cage联合钛板固定应用于治疗颈椎病的前路融合手术。

英文摘要:

  【Abstract】 Objectives: To compare the clinical efficacy of double-way connection intervertebral fusion device (ROI-C) or traditional cage with titanium plate in the treatment of cervical myelopathy, analysis of ROI-C in the clinical efficacy of anterior cervical operation application. Methods: From June 2011 to December 2013, a total of 104 patients with the cervical myelopathy was treated with ACDF or ROI-C in our department. The double-way connection intervertebral fusion device(ROI-C) was applied in 46 patients with a total of 89 segments as group A. Cage and titanium plate implantation were used in 58 patients with 106 segments as group B. Antero-posterior and lateral X-rays, flexion-extension X-ray, CT scan and MRI were performed preoperatively. Antero-posterior and lateral X-rays were performed 3 days, 3 months, 6 months and 12 months after operation. Flexion-extension X-rays were made 3 months, 6 months and 12 months postoperatively. Operation time, intraoperative blood loss, incidence of postoperative dysphagia, JOA scores and VAS scores, Cobb angle, the height of intervertebral space, fusion rate and complications were observed in both groups. Results: Patients were followed up for 3 to 36 months, averaging 18 months. The operation time in group A was 73.2±8.1min for single level, 127.4±13.4min for two levels, 152.7±19.4min for three levels; the amount of bleeding was 62.3±20.2ml for single level, 83.2±32.4ml for 2 levels, 110.5±54.3ml for 3 levels, all were significantly lower than those of group B(operation time: 84.3±7.2min for single level, 147.6±13.1min for two levels, 184.1±21.3min for three levels; the amount of bleeding: 100.2±22.1ml for single level, 128.3±35.3ml for 2 levels, 190.6±57.2ml for 3 levels), the differences were statistically significant(P<0.05). In group A, preoperative and postoperative JOA score was 9.49±0.83 and 12.45±1.00 respectively, while 9.21±1.00 and 12.04±0.89 in group B, postoperative JOA score improved significantly compared with preoperative ones(P<0.05). In group A, preoperative and postoperative VAS score was 2.94±0.56 and 1.24±0.44 respectively, while 2.88±0.54 and 1.26±0.43 in group B, postoperative VAS score improved significantly compared with preoperative ones(P<0.05), while no difference was noted between two groups either before or after operation(P>0.05). In group A, preoperative and postoperative Cobb angle was 20.35°±7.12° and 26.82°±6.13° respectively, while 18.34°±7.32° and 25.32°±8.91° in group B, postoperative cervical lordosis(Cobb angle) was better than that of preoperation(P<0.05), but no significant difference was noted between two groups(P>0.05). In group A, preoperative and postoperative intervertebral height was 5.83±1.02mm and 8.47±1.83mm respectively, while 5.54±1.82mm and 8.03±2.43mm in group B, postoperative intervertebral height was higher than that of preoperation(P<0.05), while no significant difference was noted between two groups(P>0.05). In group A, postoperative dysphagia occurrence rate was 6.52%, only 3 cases of 46 patients suffered from mild dysphagia and were relieved in 1 month. In group B, postoperative dysphagia occurred in 34.48% of patients, in 58 patients, mild dysphagia was noted in 13 cases, moderate dysphagia in 7 cases. Dysphagia rate in group A was obviously lower than that in group B(P<0.05). At final follow-up, 45 patients in group A got bony fusion, with the fusion rate of 97.8%; 55 cases in group B got bony fusion, with the fusion rate of 94.8%; no significant difference was noted between the two groups(P>0.05). No tracheal, esophageal injury or recurrent laryngeal nerve injury was noted in 2 groups. Conclusions: Cervical intervertebral fusion cage bridge shaped locking(ROI-C) can effectively restore cervical lordosis and intervertebral height, can obtain satisfactory rate of fusion, the operation is relatively simple, short operation time, intraoperative bleeding is less, less tissue injury, postoperative dysphagia occurrence rate is low, is expected to replace the anterior cage combined with titanium plate fixation for treatment of cervical spondylosis fusion operation.