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)

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（ROIC）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。

Objectives：To evaluate the efficacy and safety of anterior cervical discectomy and fusion（ACDF）by using zero-profile anchored spacer（ROI-C）.Methods：105 pa tients（76 males,29 females,average age53.64±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 in76 cases,two levels in 23 cases,three levels in 5 cases,four levels in 1 case.The demographic data,opera-tion 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 eval-uated.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 ±96.72 ml.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 ±0.41 mm at preoperation,5.03±1.11 mm 6 months after surgery,and 4.62 ±0.88 mm 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.