Center for Spinal Surgery and Neurotraumatology, BG Unfallklinik Frankfurt am Main gGmbH, Friedberger Landstraße 430, 60389, Frankfurt am Main, Germany.
Neurosurgical Department, Acıbadem University Vocational School of Health Services, Istanbul, Turkey.
Eur Spine J. 2020 Nov;29(11):2814-2822. doi: 10.1007/s00586-020-06454-z. Epub 2020 May 19.
Stand-alone zero-profile devices have already proven safety, and a reduced dysphagia rate was assumed. So far, no level-one evidence is available to prove the proposed advantages of zero-profile implants in multilevel procedures. The aim of this RCT was to compare the clinical and radiological outcome of a zero-profile spacer versus cage + plate in two-level ACDF.
Consecutive patients with contiguous two-level cDD were randomly assigned either to the interventional group (zero-profile device) or to the control group (cage + plate). Primary endpoint of the study was the prevalence of dysphagia at 24 months. Disability, progress of adjacent segment degeneration, fusion status and loss of correction were analyzed as secondary outcome measure. Primary outcome parameter was statistically analyzed by Chi-square test.
Forty-one patients met inclusion criteria and were randomly assigned to the interventional and the control group. Dysphagia was frequent in either group at 3 months FU favoring interventional group (p = 0.078). At final FU, less patients of the interventional group complained about dysphagia, but the difference was not significant. No relevant differences at final FU were recorded for NPDI, loss of correction and adjacent-level degeneration. Fusion rate was slightly lower in the interventional group.
Two-level ACDF either by a stand-alone zero-profile spacer or cage + plate is safe. Using a zero-profile cage dysphagia was infrequent at 24 months, but the value did not reach statistical significance in comparison with the cage + plate. Hence, this randomized trial was not able to prove the proposed clinical superiority for dysphagia rates for zero-profile anchored spacer in two-level cDD.
独立的零切迹装置已被证明是安全的，且吞咽困难发生率较低。到目前为止，尚无一级证据证明在多节段手术中零切迹植入物具有所提议的优势。本 RCT 的目的是比较零切迹间隔器与 cage + plate 在双节段 ACDF 中的临床和影像学结果。
连续患有连续两节段 cDD 的患者被随机分配到干预组（零切迹装置）或对照组（cage + plate）。研究的主要终点是 24 个月时吞咽困难的发生率。残疾、相邻节段退变的进展、融合状态和矫正丢失被分析为次要观察指标。主要结局参数采用卡方检验进行统计学分析。
41 例患者符合纳入标准，并被随机分配到干预组和对照组。在 3 个月 FU 时，两组吞咽困难均较常见，干预组更常见（p = 0.078）。在最终 FU 时，干预组较少的患者抱怨吞咽困难，但差异无统计学意义。在最终 FU 时，NPDI、矫正丢失和相邻节段退变均无明显差异。干预组的融合率略低。
双节段 ACDF 无论是采用独立的零切迹间隔器还是 cage + plate 都是安全的。使用零切迹 cage 在 24 个月时吞咽困难罕见，但与 cage + plate 相比，其数值无统计学意义。因此，本随机试验未能证明在双节段 cDD 中，零切迹锚定间隔器在吞咽困难发生率方面具有所提议的临床优势。
