医学
吞咽困难
随机对照试验
统计显著性
放射性武器
临床终点
外科
电镀(地质)
神经外科
颈椎前路椎间盘切除融合术
还原(数学)
作者
Matti Scholz,B Onal,Philipp Schleicher,Andreas Pingel,Christoph-Heinrich Hoffmann,Frank Kandziora
标识
DOI:10.1007/s00586-020-06454-z
摘要
PurposeStand-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.MethodsConsecutive 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.ResultsForty-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.DiscussionTwo-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.
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