SPINE
Mid- to Long-Term Outcomes of Cervical Disc Arthroplasty versus Anterior Cervical Discectomy and Fusion for Treatment of Symptomatic Cervical Disc Disease: A Systematic Review and Meta-Analysis of Eight Prospective Randomized Controlled Trials
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(13):26 PLoS One. 2016 Feb 12;11(2):e01493128 randomized controlled trials comparing cervical disc arthroplasty (CDA) to anterior cervical discectomy and fusion (ACDF), for the treatment of symptomatic cervical disc disease (1-level or 2-level), were included. The purpose of this study was to assess the safety and efficacy of these procedures at a minimum of 48 months, through a quantitative analysis of available literature. The results indicated that patients receiving CDA displayed higher rates of overall success, Neck Disability Index success, neurological success, and lower rates of serious treatment-related adverse events and secondary procedures when compared to ACDF patients. Functional results, patient satisfaction and the incidence of superior adjacent level degeneration were significantly better in the CDA group as well.
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
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はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
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Introduction
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Accessing Data
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Analysing Data
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Results
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Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Anterior cervical discectomy and fusion (ACDF) is the standard treatment for radiculopathy and myelopathy caused by disc disease. Potential drawbacks to this procedure include pseudarthrosis and adjacent segment degeneration. Cervical disc arthroplasty (CDA) is an alternative technique that has been introduced to potentially avoid adjacent segment degeneration, as it has previously been shown to maintain segmental range of motion and cervical kinematics. However, this treatment is associated with its own adverse effects, and previous studies comparing CDA and ACDF have led to inconclusive results. The present study was conducted to clarify whether CDA provides beneficial neurological outcomes and reduced the risk of adjacent segment degeneration by quantitatively assessing the available body of evidence.
主な研究課題は何ですか？
How did the mid- to long-term efficacy and safety of cervical disc arthroplasty compare to anterior cervical discectomy and fusion, in the treatment of 1- or 2-level symptomatic cervical disc disease?
重要な知見は？
- Overall success (NDI success, neurological success, absence of implant/surgery-related serious adverse events and secondary procedures) was significantly greater in the CDA group when compared to the ACDF group (2 studies; 714 patients; RR 1.17 [95% CI 1.07, 1.28]; I2=0%; p=0.0005) as was NDI success (15 point increase) (3 studies; 999 patients; RR 1.10 [95% CI 1.04, 1.18]; I2=17%; p=0.002)
- Neurological success was significantly greater in the CDA Group vs. the ACDF group (6 studies; 1671 patients; RR 1.04 [95% CI 1.01, 1.08]; I2=9%; p=0.01)
- Implant/surgery-related serious adverse events were comparable between groups (4 studies; 1201 patients; RR 0.62 [95% CI 0.39, 1.01]; I2=0%; p=0.05). Secondary procedures were significantly less common in the CDA group (7 studies; 2037 patients; RR 0.55 [95% CI 0.42, 0.73]; I2=29%; p<0.0001). These results were confirmed in the 6 and 4 studies assessing secondary procedures at the index level and at the adjacent level, respectively.
- In terms of functional scores, significantly better scores were noted in the CDA group with respect to NDI scores (3 studies; p<0.00001), neck pain (2 studies; p<0.0001), arm pain (2 studies; p=0.05), and SF-36 PCS (2 studies; p=0.002). As well, the CDA group displayed greater overall improvements in NDI score, neck pain, and SF-36 PCS, and favourable but nonsignificant arm pain scores.
- Patient satisfaction was significantly greater in the CDA group (3 studies; 829 patients; RR 1.09 [95% CI 1.03, 1.16]; I2=0%; p=0.002), as was patient recommendation (3 studies; 829 patients; RR 1.10 [95% CI 1.05, 1.16]; I2=0%; p=0.0004) compared to the ACDF group
- Significantly less superior adjacent level degeneration was noted in the CDA group (2 studies; p<0.0001) and no differences were noted between groups in terms of the incidence of inferior adjacent level degeneration (2 studies; p=0.09)
最も覚えておくべきことは？
Patients receiving cervical disc arthroplasty displayed higher rates of overall success, Neck Disability Index success, neurological success, and lower rates of serious adverse events and secondary procedures when compared to anterior cervical discectomy and fusion. Functional results were significantly better in the CDA group, as was patient satisfaction, and the incidence of superior adjacent level degeneration was significantly lower in the CDA group.
それが私の患者ケアにどのように影響するか？
The results of this meta-analysis displayed that the mid- to long-term success rates, functional outcomes, adverse events, secondary procedures, patient satisfaction, and the incidence of superior adjacent level degeneration was significantly better in the patients receiving cervical disc arthroplasty when compared to patients receiving anterior cervical discectomy and fusion for symptomatic cervical disc disease. However, a number of these outcomes were only assessed in a few studies and should be interpreted with caution. Additionally, while these results support the use of cervical disc arthroplasty, cost-effectiveness analyses are needed before this treatment can be recommended over anterior cervical discectomy and fusion.
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