零切迹颈前路椎间融合固定系统早期疗效分析

目的探讨零切迹颈前路椎间融合固定系统（Zero—profileinterbodyfusiondevice，Zero—P）用于颈椎前路手术的初期疗效。方法2010年12月至2012年lO月，将Zero—P系统用于颈椎前路手术27例，其中神经根型颈椎病10例，脊髓型颈椎病4例，外伤性颈椎间盘突出13例。记录术前和术后3、12个月时颈部疼痛及上肢疼痛视觉模拟评分（visualanaloguescale，VAS）、颈椎功能障碍指数（neckdisabilityindex，NDI）评分、日本骨科协会（Japaneseortho．paedicassociation，JOA）评分、SF一36评分、颈椎曲度Cobb角及术后吞咽困难发生率。结果24例为单节段手术，3例为双节段手术，手术顺利，术中无明显严重并发症。手术时间（72±15）min，术中出血量（52．0±18．5）mL。术后随访6～27个月，平均13．5个月，无一例内固定失败。所有患者颈部及双上肢疼痛明显改善，颈部VAS评分由术前（6．7±2．O）分降低到末次随访时（1．9±0．8）分（P〈0．05），上肢疼痛由（5．5±1．6）分降低到（2．0±O．9）分，差异有统计学意义（P〈0．05）；颈椎功能明显改善，NDI评分由（44．21±11．50）％降低到（14．73±9．04）％，差异有统计学意义（P〈0．05）；术后神经功能均有所改善，JOA评分由（8．3±3．4）分提高到（14．6±5．1）分，差异有统计学意义（P〈0．05）；术后患者生存质量明显改善，SF-36中物理评分从（29．5±7．4）％改善至（50．6±9．1）％，心理评分从（33．7±6．4）％改善至（52．9±8．4）％，差异有统计学意义（P〈0．05）。颈椎曲度Cobb角由术前（8．7±7．1）。改善至末次随访时（15．1±8．4）°，差异有统计学意义（P〈0．05）。术后1个月时有4例患者（其中女性3例，男性1例）出现轻度吞咽困难，3个月时仍有1例，6个月时完全消失。结论Zero—P系统用于颈椎前路手术操作简单，可显著减少术后吞咽困难发生率，有效改善颈椎曲度，早期临床疗效满意，中远期疗效有待进一步观察。

Early Follow - up Outcomes of a New Zero - profile Implant Used in Anterior Cervical Discectomy and Fusion

Objective To analyze the primary efficacy and safety of a new zero - profile implant named Zero - P in anteri- or cervical discectomy and fusion （ACDF）. Methods From December 2010 to October 2012,27 patients underwent anterior cervical operation with Zero - P. There were 10 cases of cervical spondylotic radiculopathy,3 of myelopathy and 10 of cervical injury associated cervical disc hemiation. The VAS score for neck and arm pain,NDI seore,JOA score,SF -36 stores,cervical Cobb angle and dysphagia- related symptoms were reviewed respectively before operation and 3 months and 12 months after operation. Results All 27 cases were followed up from 6 to 27 months and there were none of implant - related complication. The surgery lasted an average of 72 rain （range ,50 to 110 rain） ,mean blood loss was 52.0 mL （range, from 40 to 132 mL）. The sign and neurologie symptom in all cases had significant improvement. The VAS for neck and arm pain were all significant- ly improved from （6.7 ±2. O） and （5.5 ± 1.6） to （ 1.9 ± 0.8 ） and （2.0 ±O. 9 ） respectively （ P 〈 O. 05 ）. The JOA score andNDI score were significantly improved from （ 8.3 ± 3.4 ） to （ 14.6± 5. 1 ） and from （ 44.21 ± 1 1.5 0 ） % to （ 14.7 3 ± 9.04） % （P 〈 O. 05 ）. The mean physical component of SF - 36 （PCS） improved from （29.5±7.4） % to （50.6 ± 9.1 ） %, the mean mental component of SF - 36 （MCS） improved from （33.7 ± 6.4） % to （2.9 ± 8.4） %. The cervical Cobb angle im- proved from （8.7 ± 7.1 ） o to （ 15.1 ± 8.4） °. There were 4 of 27 patients complained of minor dysphagia at 1 month after opera- tion, only one at 3 month after operation and none at 6 month after operation. Conclusion The primary clinical and radio- graphic efficacy of Zero - P used in ACDF is satisfactory. The device can improve and maintain the cervical lordosis. The inci- dence of postoperative dysphagia is low.＇More patients and longer follow - up are demanded to confirm the results obtained in this study.