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临床实践中无颈椎间盘假体应用的理由:一项随机对照试验的荟萃分析。

No justification for cervical disk prostheses in clinical practice: a meta-analysis of randomized controlled trials.

机构信息

Radboud University Nijmegen Medical Centre, Department of Neurosurgery, Nijmegen, Netherlands.

出版信息

Neurosurgery. 2010 Jun;66(6):1153-60; discussion 1160. doi: 10.1227/01.NEU.0000369189.09182.5F.


DOI:10.1227/01.NEU.0000369189.09182.5F
PMID:20421840
Abstract

OBJECTIVE: A meta-analysis was performed to evaluate whether a beneficial clinical effect of cervical disk prostheses over conventional cervical diskectomy with fusion exists. METHODS: A literature search was completed ending February 4, 2009, that included the abstract books of recent major spine congresses. All studies reported the results of single-level cervical disease without myelopathy. The Visual Analog Score (VAS) of the arm, VAS of the neck, Neck Disability Index, Physical Composite Scores of the Short Form 36, and Mental Composite Score of the Short Form 36, as well as adverse events, were evaluated. RESULTS: Nine records were found, totaling 1533 patients. Of these, 1165 were evaluable at the last follow-up at 12 or 24 months. As an effect measure, a pooled odds ratio (OR) was calculated at 12 and 24 months. At 12 months, the VAS arm reached statistical significance (OR = 0.698; 95% confidence interval [CI], 0.571-0.853), as did the VAS neck (OR = 0.690; 95% CI, 0.562-0.847), and the Physical Composite Scores (OR = 1.362; 95% CI, 1.103-1.682) and the Mental Composite Score (OR = 1.270; 95% CI, 1.029-1.569) of the Short Form 36, favoring arthroplasty. The Neck Disability Index at 24 months also reached statistical difference (OR = 0.794; 95% CI, 0.641-0.984). All other measurements did not reveal any statistical difference. The number of complications, including secondary surgeries for adjacent segment disease, did not differ. CONCLUSION: A clinical benefit for the cervical disk prosthesis is not proven. Because none of the studies were blinded, bias of the patient or researcher is a probable explanation for the differences found. Therefore, these costly devices should not be used in daily clinical practice.

摘要

目的:通过荟萃分析来评估颈椎间盘假体与传统颈椎间盘切除术加融合术相比是否具有更好的临床效果。

方法:文献检索截至 2009 年 2 月 4 日,包括最近主要脊柱大会的摘要集。所有研究均报告了无脊髓病的单节段颈椎疾病的结果。评估的指标包括手臂视觉模拟评分(VAS)、颈部 VAS、颈部残疾指数、简明 36 健康调查量表的身体综合评分和精神综合评分,以及不良事件。

结果:共找到 9 条记录,总计 1533 例患者。其中,1165 例患者在 12 或 24 个月的最后随访时可评估。作为效应量,计算了 12 个月和 24 个月时的合并优势比(OR)。在 12 个月时,手臂 VAS 达到统计学意义(OR=0.698;95%置信区间[CI],0.571-0.853),颈部 VAS(OR=0.690;95%CI,0.562-0.847),以及简明 36 健康调查量表的身体综合评分(OR=1.362;95%CI,1.103-1.682)和精神综合评分(OR=1.270;95%CI,1.029-1.569)也具有统计学意义,有利于关节成形术。24 个月时的颈部残疾指数也达到了统计学差异(OR=0.794;95%CI,0.641-0.984)。其他所有测量指标均未显示出任何统计学差异。包括相邻节段疾病的二次手术在内的并发症数量没有差异。

结论:颈椎间盘假体的临床获益未得到证实。由于没有一项研究是盲法的,因此患者或研究者的偏倚可能是造成差异的原因。因此,这些昂贵的器械不应该在日常临床实践中使用。

相似文献

[1]
No justification for cervical disk prostheses in clinical practice: a meta-analysis of randomized controlled trials.

Neurosurgery. 2010-6

[2]
Cervical disk prostheses in clinical practice.

Neurosurgery. 2010-11

[3]
Relaxation of forces needed to distract cervical vertebrae after discectomy: a biomechanical study.

J Spinal Disord Tech. 2009-4

[4]
Spinal arthroplasty is here to stay: editorial.

Acta Neurochir (Wien). 2010-3

[5]
Lower incidence of dysphagia with cervical arthroplasty compared with ACDF in a prospective randomized clinical trial.

J Spinal Disord Tech. 2010-2

[6]
Cervical disc replacement C5-6.

Eur Spine J. 2010-2

[7]
Anatomic midline marking during cervical arthroplasty with ProDisc-C: an alternative, simple, and reliable method: technical note.

J Spinal Disord Tech. 2009-12

[8]
Effect of two-level total disc replacement on cervical spine kinematics.

Spine (Phila Pa 1976). 2009-10-15

[9]
Hypopharyngeal injury leading to subcutaneous emphysema after anterior cervical discectomy and artificial cervical disc placement.

J Clin Neurosci. 2010-5-14

[10]
Surgery for cervical disc disease. Why go for the worst solution?

Acta Neurochir (Wien). 2010-7

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The role of biomechanical factors in models of intervertebral disc degeneration across multiple length scales.

APL Bioeng. 2023-5-8

[2]
Safety and Validity of Anterior Cervical Disc Replacement for Single-level Cervical Disc Disease: Initial Two-year Follow-up of the Prospective Observational Post-marketing Surveillance Study for Japanese Patients.

Neurol Med Chir (Tokyo). 2022-11-15

[3]
Prospective Multicenter Trial of Cervical Arthroplasty with the ROTAIO® Cervical Disc Prosthesis.

Global Spine J. 2024-3

[4]
Quality assessment of systematic reviews of surgical treatment of cervical spine degenerative diseases: an overview.

Einstein (Sao Paulo). 2022

[5]
Cervical Arthroplasty: Long-Term Outcomes of FDA IDE Trials.

Global Spine J. 2020-4

[6]
Long-term Results Comparing Cervical Disc Arthroplasty to Anterior Cervical Discectomy and Fusion: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Orthop Surg. 2019-12-21

[7]
Cervical radiculopathy: is a prosthesis preferred over fusion surgery? A systematic review.

Eur Spine J. 2020-11

[8]
Artificial disc replacement in spine surgery.

Ann Transl Med. 2019-9

[9]
Secondary Surgery after Cervical Disc Arthroplasty versus Fusion for Cervical Degenerative Disc Disease: A Meta-analysis with Trial Sequential Analysis.

Orthop Surg. 2018-8

[10]
[Operative treatment of the degenerative cervical spine].

Nervenarzt. 2018-6

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