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NEK 试验:颈椎间盘突出症前路颈椎间盘切除伴或不伴椎间融合及关节成形术的疗效:一项双盲随机对照试验。

The NECK trial: Effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blinded randomized controlled trial.

机构信息

Department of Neurosurgery, Leiden University Medical Center, Leiden, the Netherlands.

Department of Neurosurgery, Leiden University Medical Center, Leiden, the Netherlands.

出版信息

Spine J. 2019 Jun;19(6):965-975. doi: 10.1016/j.spinee.2018.12.013. Epub 2018 Dec 21.

DOI:10.1016/j.spinee.2018.12.013
PMID:30583108
Abstract

BACKGROUND

Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent disc degeneration as compared with anterior cervical discectomy and fusion (ACDF). Prior reports suggest that ACDF is not more effective than anterior cervical discectomy (ACD) alone for the treatment of cervical radiculopathy.

PURPOSE

To evaluate whether patients with cervical radiculopathy due to a herniated disc benefit more from undergoing ACDA, ACDF, or ACD in terms of clinical outcome measured by the neck disability index (NDI).

STUDY DESIGN

Double-blinded randomized controlled trial.

METHODS

One hundred-nine patients with one level herniated disc were randomized to one of the following treatments: ACDA, ACDF with intervertebral cage, ACD without fusion. Clinical and radiological outcome was measured by NDI, Visual Analogue Scale (VAS) neck pain, VAS arm pain, SF36, EQ-5D, patients' self-reported perceived recovery, radiographic cervical curvature, and adjacent segment degeneration parameters at baseline and until two years after surgery. BBraun Medical paid €298.837 to cover the costs for research nurses.

RESULTS

The NDI declined from 41 to 47 points at baseline to 19 ± 15 in the ACD group, 19 ± 18 in the ACDF group, and 20 ± 22 in the ACDA group after surgery (p=.929). VAS arm and neck pain declined to half its baseline value and decreased below the critical value of 40 mm. Quality of life, measured by the EQ-5D, increased in all three groups. Adjacent segment degeneration parameters were comparable in all three groups as well. No statistical differences were demonstrated between the treatment groups.

CONCLUSIONS

The hypothesis that ACDA would lead to superior clinical outcome in comparison to ACDF or ACD could not be confirmed during a 2-year follow-up time period. Single level ACD without implanting an intervertebral device may be a reasonable alternative to ACDF or ACDA.

摘要

背景

与前路颈椎间盘切除融合术(ACDF)相比,颈椎神经根病患者采用保留运动的前路颈椎间盘置换术(ACDA)可预防症状性相邻椎间盘退变。先前的报告表明,对于颈椎神经根病的治疗,ACDF 并不比单纯前路颈椎间盘切除术(ACD)更有效。

目的

评估颈椎间盘突出症患者接受 ACDA、ACDF 或 ACD 治疗后,通过颈残障指数(NDI)测量的临床结果,哪种治疗方式获益更多。

研究设计

双盲随机对照试验。

方法

109 例单节段椎间盘突出症患者随机分为以下治疗组之一:ACDA、带椎间融合器的 ACDF、无融合的 ACD。通过 NDI、视觉模拟量表(VAS)颈部疼痛、VAS 手臂疼痛、SF-36、EQ-5D、患者自我报告的感知恢复、影像学颈椎曲度和相邻节段退变参数来测量临床和影像学结果,基线和术后 2 年。Braun Medical 支付了 298837 欧元用于支付研究护士的费用。

结果

NDI 从基线时的 41 分降至 47 分,至 ACD 组术后的 19 ± 15 分、ACDF 组的 19 ± 18 分和 ACDA 组的 20 ± 22 分(p=.929)。手臂和颈部 VAS 疼痛均下降至基线值的一半,且降至 40mm 的临界值以下。所有三组的生活质量(EQ-5D)均有所提高。所有三组的相邻节段退变参数也相似。治疗组之间无统计学差异。

结论

在 2 年的随访期间,ACDA 与 ACDF 或 ACD 相比会产生更好的临床结果这一假设无法得到证实。无植入物的单节段 ACD 可能是 ACDF 或 ACDA 的合理替代方案。

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