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Kyphoplasty superior to vertebroplasty for osteoporotic vertebral compression fractures
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SPINE

A meta-analysis of balloon kyphoplasty compared to percutaneous vertebroplasty for treating osteoporotic vertebral compression fractures

OrthoEvidence Journal (OE Journal) - ACE Report

OE Journal. 2013;1(13):23 J Clin Neurosci. 2013 Jun;20(6):795-803. doi: 10.1016/j.jocn.2012.05.038. Epub 2013 Feb 18.

10 trials (783 patients) were analyzed in this meta-analysis to compare the safety and efficacy between balloon kyphoplasty (KP) and percutaneous vertebroplasty (VP) in the treatment of osteoporotic vertebral compression fractures (OVCF). The meta-analysis found that balloon kyphoplasty had significantly better long term results (longer than 6 months) in terms of kyphosis angle, anterior height of the vertebral body, and cement leakage rates. No between-group differences were found in short and long term visual analog scale (VAS) pain and Oswestry-Disability Index scores, operative times, short term kyphosis angle, or adjacent-level fracture rates.


出版資金提供の詳細 +
資金提供:
Non-funded
コンフリクト:
None disclosed

バイアスのリスク

10/10

報告基準

18/20

脆弱性指数

N/A

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?

How would you rate the scientific quality of this evidence?

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。

4/4

Introduction

4/4

Accessing Data

4/4

Analysing Data

3/4

Results

3/4

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?

Worldwide, osteoporotic vertebral compression fractures (OVCF) have detrimental effects on patients. They are responsible for decrease in anterior vertebral height, spinal deformity, reduced pulmonary function, abdominal and thoracic content restriction, impaired mobility, and depression. Two surgical procedures, vertebroplasty (VP) and kyphoplasty (KP), have demonstrated better pain relief, vertebral restoration, and mobility than conservative treatments. A previous study stated that kyphoplasty, however, had higher costs than vertebroplasty. Hence, a meta-analysis was needed to compare both surgical procedures with each other.

主な研究課題は何ですか?

What is the safety and efficacy of balloon kyphoplasty (KP) compared to percutaneous vertebroplasty (VP) in treatment of osteoporotic vertebral compression fractures (OVCF)?

研究の特徴 +
データソース:
The primary search for peer-reviewed RCTs, published until end of May 2012, was conducted using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) on MEDLINE, Embase, ScienceDirect, Ovid, and Cochrane Central Register of Controlled Trials (CENTRAL) databases. The secondary search was conducted on the Wold Health Organization’s International Clinical Trials Registry Platform, the UK National Research Register Archive and Current Controlled Trials for unpublished articles until March 1, 2012.
索引用語:
The index terms used were: kyphoplasty, vertebral compression fracture, osteoporosis, and vertebroplasty.
研究の選択:
Two independent reviewers selected 10 RCTs (783 patients), comparing kyphoplasty to vertebroplasty, in treatment of osteoporotic vertebral compression fractures. The studies had to have at least one of the outcomes: operation time, subjective pain perception, quality of life evaluation, adjacent vertebral fracture incidence, bone cement leakage, vertebral body height, and kyphosis angle post-operation. Studies reporting non-osteoporotic vertebral fractures, previous surgeries performed, and degenerative spinal diseases were excluded. All disagreements were addressed until a consensus was reached. Both authors also conducted a “Risk of Bias” assessment using Cochrane Handbook for Systematic Reviews of Interventions guidelines, with a review by a third author.
データ抽出:
Two independent reviewers extracted the study characteristics, types of interventions, numbers of vertebral bodies, surgical procedures, visual analog scale (VAS) scores, the Oswestry Disability Index (ODI) scores, operation time, kyphosis angle, anterior vertebral body height, adjacent fractures and bone cement leakages. Short term results were considered as no more than 1 week, and long term results were longer than 6 months. A third reviewer rechecked the extracted data.
データ統合:
Review Manager Software (RevMan Version 5.1) was used for all data analysis. Continuous outcomes were stated as mean differences (MD) with 95% confidence intervals (CI). Dichotomous outcomes were depicted as risk ratios (RR) with 95% CI. All p<0.05 were considered significant. Sensitivity and subgroup analysis was conducted, studying sources of heterogeneity, by chi-square and I-square tests.

重要な知見は?

  • In 7 trials, reporting short term VAS no difference was found between KP and VP (MD= -0.57, 95% CI= -1.33 to 0.20; p=0.15). Similar results were seen in long term VAS scores in 9 studies (MD = -0.99, 95% CI = -2.29 to 0.31; p=0.14).
  • In 5 studies, covering ODI scores, 2 showed no differences between the groups in short term results (MD= -6.54, 95% CI = -14.57 to 1.48; p=0.11) and 5 had no differences in long term results (MD= -2.01, 95% CI -11.75 to 7.73; p = 0.69).
  • 2 trials indicated no differences in operative times between KP and VP (MD = 4.47, 95% CI = -0.22 to 9.17; p=0.06).
  • 3 studies found no differences in short term kyphosis angle after operation (MD= -2.25, 95% CI= -5.14 to 0.65; p=0.13). However, in 4 trials, the long term kyphosis angle was better with KP (MD=-2.64, 95% CI = -4.66 to -0.61; p=0.01).
  • 4 trials reported better anterior height restoration of the vertebral body in KP (MD= 3.67, 95% CI =1.40 to 5.94; p =0.002).
  • 9 studies also suggested a lower cement leakage rate in KP (RR=0.70, 95% CI =0.52 to 0.95; p=0.02).
  • In 7 trials, no differences were seen between two procedures in adjacent vertebral compression fractures (RR=1.52, 95% CI = 0.76 to 3.03; p = 0.24).
最も覚えておくべきことは?

The analyzed data suggested that kyphoplasty and vertebroplasty had similar operative time, pain relief, and functional scores in the treatment of osteoporotic vertebral compression fractures. However, kyphoplasty resulted in better long term kyphosis angle, restoration of vertebral body height, and lower risk of cement leakage.

それが私の患者ケアにどのように影響するか?

Although the study supports the use of kyphoplasty for better kyphosis angle, vertebral height restoration, and lower risk of cement leakages, the methodological quality and risk of bias of the studies was poor. Further trials still need to be conducted on this topic.

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引用方法 ACE Report

OrthoEvidence. Kyphoplasty superior to vertebroplasty for osteoporotic vertebral compression fractures. OE Journal. 2013;1(13):23. Available from: https://myorthoevidence.com/AceReport/Show/

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