BACKGROUND Posterior cervical foraminotomy (posterior surgery) is a valid alternative to anterior discectomy with fusion (anterior surgery) as a surgical treatment of cervical radiculopathy, but the quality of evidence has been limited. The purpose of this study was to compare the clinical outcome of these treatments after 2 years of follow-up. We hypothesized that posterior surgery would be noninferior to anterior surgery. METHODS This multicenter, randomized, noninferiority trial assessed patients with single-level cervical radiculopathy in 9 Dutch hospitals with a follow-up duration of 2 years. The primary outcomes measured reduction of cervical radicular pain and were the success ratio based on the Odom criteria, and arm pain and decrease in arm pain, evaluated with the visual analog scale, with a 10% noninferiority margin, which represents the maximum acceptable difference between the new treatment (posterior surgery) and the standard treatment (anterior surgery), beyond which the new treatment would be considered clinically unacceptable. The secondary outcomes were neck pain, Neck Disability Index, Work Ability Index, quality of life, complications (including reoperations), and treatment satisfaction. Generalized linear mixed effects modeling was used for analyses. The study was registered at the Overview of Medical Research in the Netherlands (OMON), formerly the Netherlands Trial Register (NTR5536). RESULTS From January 2016 to May 2020, 265 patients were randomized (132 to the posterior surgery group and 133 to the anterior surgery group). Among these, 25 did not have the allocated intervention; 11 of these 25 patients had symptom improvement, and the rest of the patients did not have the intervention due to various reasons. At the 2-year follow-up, of 243 patients, primary outcome data were available for 236 patients (97%). Predicted proportions of a successful outcome were 0.81 after posterior surgery and 0.74 after anterior surgery (difference in rate, -0.06 [1-sided 95% confidence interval (CI), -0.02]), indicating the noninferiority of posterior surgery. The between-group difference in arm pain was -2.7 (1-sided 95% CI, 7.4) and the between-group difference in the decrease in arm pain was 1.5 (1-sided 95% CI, 8.2), both confirming the noninferiority of posterior surgery. The secondary outcomes demonstrated small between-group differences. Serious surgery-related adverse events occurred in 9 patients (8%) who underwent posterior surgery, including 9 reoperations, and 11 patients (9%) who underwent anterior surgery, including 7 reoperations (difference in reoperation rate, -0.02 [2-sided 95% CI, -0.09 to 0.05]). CONCLUSIONS This trial demonstrated that, after a 2-year follow-up, posterior surgery was noninferior to anterior surgery with regard to the success rate and arm pain reduction in patients with cervical radiculopathy. LEVEL OF EVIDENCE Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

中文翻译：

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颈椎后孔切开术与颈椎前路椎间盘切除术融合治疗神经根型颈椎病的比较：FACET 随机非劣效性研究的两年结果。


背景 颈椎后孔切开术（后路手术）是前椎间盘切除术联合融合术（前路手术）作为神经根型颈椎病手术治疗的有效替代方案，但证据质量有限。本研究的目的是比较这些治疗在 2 年随访后的临床结果。我们假设后路手术不劣于前路手术。方法 这项多中心、随机、非劣效性试验评估了 9 家荷兰医院的单节段神经根型颈椎病患者，随访时间为 2 年。主要结局测量了颈椎神经根痛的减轻，是基于 Odom 标准的成功率，以及手臂疼痛和手臂疼痛减轻，用视觉模拟量表评估，非劣效性为 10%，这代表了新治疗（后路手术）和标准治疗（前路手术）之间的最大可接受差异， 超过此时间，新的治疗方法将被视为临床上不可接受。次要结局是颈部疼痛、颈部残疾指数、工作能力指数、生活质量、并发症（包括再次手术）和治疗满意度。采用广义线性混合效应模型进行分析。该研究在荷兰医学研究概述 （OMON） 注册，前身为荷兰试验注册库 （NTR5536）。结果 从 2016 年 1 月至 2020年5月，随机分配了 265 例患者 （后路手术组 132 例，前路手术组 133 例）。其中，25 例没有接受分配的干预;这 25 例患者中有 11 例症状改善，其余患者由于各种原因没有接受干预。 在 2 年随访中，在 243 名患者中，有 236 名患者 （97%） 的主要结局数据可用。后路手术后成功结局的预测比例为 0.81，前路手术后 0.74 （率差，-0.06 [1 侧 95% 置信区间 （CI），-0.02]），表明后路手术的非劣效性。手臂疼痛的组间差异为 -2.7 （1 侧 95% CI，7.4），手臂疼痛减轻的组间差异为 1.5 （1 侧 95% CI，8.2），均证实了后路手术的非劣效性。次要结局显示组间差异较小。9 例接受后路手术的患者 （8%） 发生严重手术相关不良事件，包括 9 例再次手术，11 例 （9%） 接受前路手术，包括 7 例再次手术 （再手术率差异，-0.02 [2 侧 95% CI，-0.09 至 0.05]）。结论 该试验表明，经过 2 年的随访，神经根型颈椎病患者后路手术的成功率和手臂疼痛减轻率不劣于前路手术。证据级别 治疗 I 级 .有关证据级别的完整描述，请参阅作者说明。