零切迹自稳型颈椎融合器（ROI-C）在颈椎前路减压融合术中的安全性与有效性评价

The clinical efficacy and safety of anterior discectomy and fusion by using zero-profile anchored spacer(ROI-C)

中文关键词:  颈椎病  脊柱融合  假体与置入物  临床疗效

英文关键词:Cervical spondylosis  Spinal fusion  Protheses and implant  Clinical efficacy

中文摘要:

  【摘要】 目的：评价颈椎前路椎间减压融合术中应用零切迹自稳型颈椎融合器（ROI-C）的安全性及临床疗效。方法：回顾性分析我院自2012年3月～2014年3月行颈椎前路椎间减压及ROI-C植骨融合的105例手术患者，其中男性76例，女性29例，年龄平均53.64±11.13岁（20～77岁）；单节段76例，双节段23例，三节段5例，四节段1例，共置入ROI-C融合器141枚。记录手术时间、出血量和术后患者吞咽不适的发生率，采用VAS、JOA、NDI评价临床疗效，并利用影像学资料测量术前、术后颈椎曲度和融合节段椎间高度的变化。结果：105例患者均获得随访，随访时间平均22.80±7.04个月（12～36个月）。平均手术时间138.34±38.14min，平均手术出血量40.76±96.72ml。术前VAS评分为4.22±0.85分，术后6个月为1.48±0.62分，末次随访时为1.02±0.64分，与术前相比均具有统计学差异（P<0.01）。术前JOA评分为9.84±2.02分，术后6个月为14.2±71.81分，末次随访时为14.83±1.61分，与术前相比差异有统计学意义（P<0.01）。术前NDI评分为39.74±3.69分，术后6个月为12.71±2.82分，末次随访时为10.84±2.14分，均较术前明显改善（P<0.01）。术前颈椎曲度平均为13.58°±7.51°，术后6个月为18.59°±7.11°，末次随访时为19.05°±6.95°，与术前相比有显著性差异（P<0.01）。术前椎间隙高度为3.19±0.41mm，术后6个月为5.03±1.11mm，末次随访时为4.62±0.88mm，与术前相比差异有统计学意义（P<0.05）。末次随访时所有患者均获得良好的骨性融合。术后早期患者吞咽不适和声音沙哑的发生率分别为4.76%（5/105）和7.62%（8/105），术后6个月上述症状均消失。本组患者随访期间均未发生术后伤口血肿或感染、内置物松动、移位或断裂等并发症。结论：颈椎前路椎间减压融合术中应用零切迹自稳型颈椎融合器（ROI-C）安全、有效，可以获得满意的早期临床疗效，并且改善和维持颈椎整体曲度和椎间隙高度，减少患者术后吞咽不适和声音嘶哑情况的发生。

英文摘要:

  【Abstract】 Objectives: To evaluate the efficacy and safety of anterior cervical discectomy and fusion(ACDF) by using zero-profile anchored spacer(ROI-C). Methods: 105 patients(76 males, 29 females, average age 53.64±11.13 years old, ranging from 20 to 77 years old) who underwent ACDF with ROI-C from March 2012 to March 2014 were evaluated in this study. A total of 141 segments was involved, including single level in 76 cases, two levels in 23 cases, three levels in 5 cases, four levels in 1 case. The demographic data, operation time and operative bleeding were observed. VAS, NDI and JOA(17) scores were used to evaluate the pre- and post-operative outcome. The fusion rate, intervertebral space and cervical curvature were also evaluated. Results: 105 patients were followed up average 22.80±7.04 months(ranging from 12 to 36 months). The average operation time was 138.34±38.14 minutes, the average operative bleeding was 40.76±96.72ml. The VAS score was (4.22±0.85) points at preopetation, (1.48±0.62) points 6 months after surgery, and (1.02±0.64) points at the final follow-up. The JOA and NDI scores were (9.84±2.02) and (39.74±3.69) points at preoperation, (14.27±1.81) and (12.71±2.82) points 6 months after surgery, (14.83±1.61) and (10.84±2.14) points at the final follow-up. The cervical curvature was 13.58°±7.51° at preoperation, 18.59°±7.11° 6 months after surgery, and 19.05°±6.95° at the final follow-up. The intervertebral space was 3.19 ±0.41mm at preoperation, 5.03±1.11mm 6 months after surgery, and 4.62±0.88mm at the final follow-up. The fusion rate 6 months after operation was 96.19%. And all the cases got bone fusion in 12 months after surgery. 5 of them had postoperative dysphagia, 8 of them had rustiness, with no other complication. Conclusions: ACDF by using the ROI-C in the treatment of cervical spondylosis has a good clinical efficacy, and complication rate is low.