SPINE
Cervical Total Disc Replacement is Superior to Anterior Cervical Decompression and Fusion: A Meta-Analysis of Prospective Randomized Controlled Trials
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2015;3(9):23 PLoS One. 2015 Mar 30;10(3):e011782619 randomized controlled trials were included in this systematic review and meta-analysis comparing outcomes following cervical disc arthroplasty (CDA) versus anterior cervical discectomy and fusion (ACDF). CDA resulted in lower Neck Disability Index scores and greater rates of at least a minimum 15-point improvement on the NDI, lower pain scores, higher range of motion at the operated level, lower rates of secondary surgery at the operated level in the short- and mid-term, lower rates of secondary surgery at adjacent levels in the short-term, and higher rate of overall success (min. 15-pt improvement in NDI, improvement or maintenance of neurological status, and no experience of severe adverse event) when compared to ACDF.
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
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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？
Degenerative cervical disc disease is a relatively prevalent condition causing neck pain and disability. In patients unresponsive to conservative treatment, surgery may be considered. Anterior cervical decompression and fusion (ACDF) has long been performed in these cases, although more recently, cervical disc arthroplasty (CDA) has emerged as an effective treatment method. A recent point of interest in comparisons between these two methods of treatment is the incidence of adjacent segment degeneration, which is currently debated.
主な研究課題は何ですか？
How does efficacy and safety compare between CDA and ACDF in the treatment of cervical disc disease?
重要な知見は？
- NDI scores were significantly lower with CDA versus ACDF at both short-term (6 studies; SMD -0.35 [95%CI -0.68, 0.00]; p=0.05) and mid-term follow-up (2 studies; SMD -0.31 [95%CI -0.47, -0.15]; p=0.0002). Rate of NDI improvement >15 pts was also significantly higher with CDA versus ACDF (5 studies; OR 0.72 [95%CI 0.54, 0.95]; p=0.02).
- NRS and VAS neck pain scores were both demonstrated to be significantly lower with CDA versus ACDF at short-term follow-up (p=0.04 and 0.004, respectively). VAS arm pain scores were also significantly lower with CDA (p=0.02), though no significant difference was observed for NRS arm pain (p=0.56). Both NRS neck and arm pain scores at mid-term follow-up were significantly lower with CDA versus ACDF (p=0.0008 and 0.02, respectively).
- Short-term SF-36 PCS and MCS scores demonstrated no significant differences between CDA and ACDF in health-related quality of life (PCS: SMD -0.07 [95%CI -0.20, 0.06], p=0.28; MCS: SMD 0.05 [95%CI -0.13, 0.22], p=0.62).
- CDA demonstrated significantly higher range of motion (ROM) at the operated level compared to ACDF (SMD -5.20 [95%CI -6.77, -3.72]; p<0.00001). No difference was noted between CDA and ACDF when considering ROM of the superior level (SMD 0.42 [95%CI -0.28, 1.12]; p=0.24) or inferior level (SMD -0.90 [95%CI -1.84, 0.04]; p=0.06).
- In the short-term, CDA demonstrated lower rates of secondary surgery at both the operated level (OR 0.32 [95%CI 0.19, 0.53]; p<0.00001) and adjacent levels (OR 0.28 [95%CI 0.11, 0.72]; p=0.008). In the mid-term, rate of secondary surgery at the operated level remained significantly lower following CDA (OR 0.45 [95%CI 0.29, 0.68]; p=0.0002), though the difference in rate of secondary surgery at adjacent levels was no longer significant (OR 0.76 [95%CI 0.47, 1.22]; p=0.25).
- Rate of overall success (defined as min. 15-pt improvement in NDI, improvement or maintenance of neurological status, and no experience of severe adverse event) was significantly higher following CDA compared to ACDF (OR 0.59 [95%CI 0.48, 0.74]; p<0.00001).
最も覚えておくべきことは？
Cervical disc arthroplasty was statistically favoured when considering pooled results of Neck Disability Index outcome at short and mid-term, neck pain in the short- and mid-term, range of motion at the operated level in the short-term, secondary surgery at the operated and adjacent levels in the short-term, secondary surgery at the operated level in the mid-term, and overall success rate when compared to anterior cervical discectomy and fusion.
それが私の患者ケアにどのように影響するか？
The results of this review and meta-analysis suggest that outcomes may be favourable following cervical disc arthroplasty when compared to anterior cervical disc arthroplasty. Additional studies with extended follow-up, and examining the progression of adjacent segment degeneration over the long-term are needed to more widely explore the long-term efficacy of these two surgical treatment options.
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