Zero-P用于颈椎前路手术的早期临床疗效分析

目的探讨Zero—P内固定系统用于颈椎前路手术的早期临床疗效。方法2010年9月-2011年6月采用Zero-P内固定系统治疗颈椎椎间盘突出症患者2I例，其中男13例，女8例。本组中有2例行双节段Zero—P内固定术。记录视觉模拟量表（visualanalogscale，VAS）评分（10分法），日本骨科学会（JapaneseOrthopaedicAssociation，JOA）评分（17分法）及吞咽困难等级。术后3—12个月复查颈椎正侧位X线片，评价内固定效果。结果单节段手术时间为（60±20）min，2例双节段手术时间分别为120min及135min，术中出血量为60～90mL（平均84mL）。术后6周VAS评分改善明显，与术前相比差异有统计学意义（P〈0．01）。术后3个月JOA评分改善率为（74±11）％．有8例患者于术后2～5d表现出轻度吞咽困难，其中1例术后3个月随访时仍有轻度吞咽困难，但6个月随访时患者症状消失。术后随访1年未发现内置物沉降，也未发生螺钉松动、断裂或内固定器移位等并发症。结论这种新型零切迹内置物系统操作简单，手术时间短，术中出血量少，早期临床疗效满意，理论上可有效降低钢板置人所导致的并发症，但仍需作大样本随机对照试验的随访调查。

Short-term clinical efficacy of a new Zero-profile implant for stand-alone anterior cervical interbody fusion

Objective To evaluate the short-term clinical efficacy of the new implant Zero-P system for patients treated by anterior cervical discectomy and fusion.Methods From September 2010 to June 2011,21 cases suffering from cervical disc herniation underwent anterior cervical discectomy and fusion using the new implant.There were 13 males and 8 females,and 19 patients with monosegmental operation,2 patients with bisegmental.The visual analog scale(VAS) score,Japan Orthopaedic Association(JOA) score and dysphagia scores were evaluated.The X-ray films were used to evaluate the efficacy of the new implant from 3 months to 1 year postoperatively.Results The operation time was(60 ± 20) min in patients operated with monosegmental,120 min and 135 min with bisegmental respectively.The intraoperative blood loss was 60-90 mL(a mean of 84 mL).Compared to preoperation,VAS of neck / arm pain and radiculopathy were reduced at 6 weeks follow-up.The rate of JOA score improvement was(74 ± 11) %.After operation,8 patients complained about minor dysphagia-related symptoms,who mended at 6 months.There was no hardware failure recordable.Conclusion The new cervical stand-alone anterior fusion device is easy to operate with low complication rates.However,prospective randomized trials with more patients and longer follow-up are necessary to confirm these observations.