Yang Haisong, Chen Deyu, Wang Xinwei, Yang Lili, He Hailong, Yuan Wen
Department of Orthopaedics, Changzheng Hospital, No. 415 Fengyang Road, Shanghai, 200003, China.
Arch Orthop Trauma Surg. 2015 Jun;135(6):781-7. doi: 10.1007/s00402-015-2212-z. Epub 2015 Apr 8.
STUDY DESIGN: Retrospective case-control study. PURPOSE: To compare the safety and efficacy of the Zero-profile (Zero-p) integrated plate and spacer device to that of an anterior cervical plate and cage in patients undergoing anterior cervical discectomy and fusion (ACDF). Anterior cervical plating system has provided good results, including higher fusion rate and improved alignment since its use. However, adjacent-level ossification development (ALOD) and dysphagia have been usually reported associating with plates. METHODS: This was a retrospective control study. Sixty-two patients with cervical radiculopathy or myelopathy were treated with an anterior plate and cage or Zero-p implant between January 2011 and December 2011. The mean follow-up was 33.1 months in the plate and cage group and 30.6 months in Zero-p group. Patient demographics, operative details and complications were reviewed. The clinical outcomes were evaluated using the Japanese Orthopaedic Association (JOA) scores and JOA recovery rate before and after operations. Incidence of cephalad and caudal ALOD on the lateral radiographs was studied at preoperation, immediate postoperation and last follow-up. Incidence of dysphagia was also recorded after operation according to Bazaz-Yoo dysphagia index. RESULTS: Thirty-two patients received an anterior plate and cage and 30 received the Zero-p implant. There were no statistical differences in patient demographics, operative details between the two groups. The JOA scores significantly increased compared with preoperational measurements in both groups (p < 0.05), but the JOA recovery rate was similar (72.2 % for plate and cage group and 77.0 % for Zero-p group, p > 0.05). ALOD occurred in 12 (18.8 %) of the 64 cephalad and caudal adjacent segments in plate with cage group, and only 1 (1.6 %) of 63 adjacent levels (including three noncontiguous cases) presented with ALOD in Zero-p group. The difference was significant (p < 0.01). The incidence of dysphagia in the Zero-p group was lower compared with that in the plate with cage group, and the symptom duration was much shorter (p < 0.01). Both groups had no adverse events associated with the implant or implant surgery. CONCLUSIONS: The Zero-profile implant is safe and efficacious after ACDF. It can reduce the rate of adjacent-level ossification development and dysphagia compared to anterior plate and cage.
研究设计：回顾性病例对照研究。 目的：比较零轮廓（Zero-p）一体化钢板及椎间融合器与前路颈椎钢板及椎间融合器在接受颈椎前路椎间盘切除融合术（ACDF）患者中的安全性和有效性。自使用以来，颈椎前路钢板系统已取得良好效果，包括更高的融合率和更好的对线。然而，通常报道钢板与相邻节段骨化发展（ALOD）及吞咽困难有关。 方法：这是一项回顾性对照研究。2011年1月至2011年12月期间，62例患有神经根型颈椎病或脊髓型颈椎病的患者接受了前路钢板及椎间融合器或Zero-p植入物治疗。钢板及椎间融合器组的平均随访时间为33.1个月，Zero-p组为30.6个月。回顾了患者的人口统计学资料、手术细节及并发症。使用日本骨科协会（JOA）评分及手术前后的JOA恢复率评估临床结果。在术前、术后即刻及末次随访时研究侧位X线片上头侧及尾侧ALOD的发生率。术后还根据Bazaz-Yoo吞咽困难指数记录吞咽困难的发生率。 结果：32例患者接受了前路钢板及椎间融合器，30例接受了Zero-p植入物。两组患者的人口统计学资料及手术细节无统计学差异。两组患者的JOA评分与术前测量值相比均显著提高（p < 0.05），但JOA恢复率相似（钢板及椎间融合器组为72.2%，Zero-p组为77.0%，p > 0.05）。钢板及椎间融合器组64个头侧及尾侧相邻节段中有12个（18.8%）发生ALOD，Zero-p组63个相邻节段（包括3个非连续病例）中仅有1个（1.6%）出现ALOD。差异有统计学意义（p < 0.01）。Zero-p组吞咽困难的发生率低于钢板及椎间融合器组，且症状持续时间短得多（p < 0.01）。两组均无与植入物或植入手术相关的不良事件。 结论：ACDF术后零轮廓植入物安全有效。与前路钢板及椎间融合器相比，它可降低相邻节段骨化发展及吞咽困难的发生率。
J Spinal Disord Tech. 2015-6
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