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Uni- vs bilateral pedicle screw fixation in minimally invasive lumbar interbody fusion
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SPINE

A Meta-Analysis of Unilateral versus Bilateral Pedicle Screw Fixation in Minimally Invasive Lumbar Interbody Fusion

OrthoEvidence Journal (OE Journal) - ACE Report

OE Journal. 2015;3(4):38 PLoS One. 2014 Nov 6;9(11):e111979.

6 studies (5 randomized controlled trials, 1 clinical controlled trial) encompassing 298 patients were included in this meta-analysis with the purpose of comparing the efficacy and safety of unilateral versus bilateral pedicle screw fixation in minimally invasive lumbar interbody fusion for one-level degenerative lumbar spine disease. Unilateral pedicle screw fixation achieved significantly shorter operative time and reduced blood loss compared to bilateral screw fixation. However, VAS back pain, VAS leg pain, ODI scores, overall fusion rate, overall incidence of complications, and length of hospital stay were similar between uni- and bilateral pedicle screw fixation.


出版資金提供の詳細 +
資金提供:
Non-Industry funded
スポンサー:
Basic-Clinical Cooperation Project in Capital Medical University, Beijing Outstanding Talent Training Project
コンフリクト:
None disclosed

バイアスのリスク

10/10

報告基準

16/20

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

3/4

Accessing Data

3/4

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?

Minimally invasive (MIS) lumbar interbody fusion is advantageous for a variety of lumbar degenerative disorders as it reduces morbidity and offers early ambulation when compared to traditional open surgery. Usually, bilateral pedicle screw (PS) fixation is the standard procedure in lumbar interbody fusion. However, recent studies suggest unilateral PS fixation is an equally effective technique that requires shorter operating time. The objective of this meta-analysis was to compare the efficacy of unilateral versus bilateral PS fixation in MIS lumber interbody fusion for one-level degenerative lumbar spine disease.

主な研究課題は何ですか?

How does the efficacy and safety compare between unilateral and bilateral pedicle screw fixation in minimally invasive lumbar interbody fusion for single-level degenerative lumbar spine disease?

研究の特徴 +
データソース:
A search for relevant studies published in peer-reviewed journals was conducted using MEDLINE/PubMed, EMBASE, BIOSIS Previews, and Cochrane Library from inception to March 30, 2014. References of selected studies were manually searched to identify additional articles.
索引用語:
Key terms included 'lumbar interbody fusion', 'pedicle screw fixation', 'minimally invasive', 'unilateral', and 'bilateral'.
研究の選択:
Full-text, English-language randomized controlled trials and clinical controlled trials published in peer reviewed journals that investigated bilateral versus unilateral pedicle screw fixation procedures in patients diagnosed with single-level lumbar degenerative disease were selected. Study retrieval was performed independently by two reviewers, and any disagreements were resolved by a third reviewer. Six studies (5 randomized controlled trials, 1 clinical controlled trial) with a total of 298 patients were selected.
データ抽出:
Data on the primary outcome measures including visual analogue leg and back pain score (VAS), Oswestry disability index (ODI), fusion rate, and complications were extracted. Secondary outcome measures including intra-operative blood loss, operating time, and hospital stay were also retrieved. The methodological quality of included studies was assessed by two authors independently.
データ統合:
Dichotomous outcomes were presented as odds ratio (OR) with 95% confidence intervals (CIs) while continuous outcomes were summarized using mean difference (MD) and 95% CI. In the absence of significant statistical heterogeneity a fixed-effect model was employed, otherwise a random-effects model was used. The summary statistic for each individual study was calculated using the meta-analysis program of the Cochrane Collaboration (Review Manager 5.2).

重要な知見は?

  • Pooled results were similar between unilateral and bilateral groups with respect to VAS back pain (5 studies: MD= -0.02 [95% CI -0.17 to 0.13]; p=0.77), VAS leg pain (3 studies: MD= -0.10 [95% CI -0.20 to 0.01]; p=0.06), and ODI scores (5 studies: MD= 0.31 [95% CI -0.66 to 1.27]; p=0.54).
  • The overall fusion rate was not significantly different between the unilateral (134/146) and bilateral (146/152) groups (OR=0.47 [95% CI 0.18 to 1.27]; p=0.14). Likewise, the overall incidence of complications was not significant different between the unilateral (8/146) and bilateral (7/152) groups (OR=1.25 [95% CI 0.44 to 3.59]; p=0.67).
  • Operative time was significantly shorter (4 studies; p=0.02) and blood loss was significantly reduced (4 studies; p=0.002) with unilateral pedicle screw fixation, but hospital stay was not significantly different between groups (3 studies; p=0.54).
最も覚えておくべきことは?

Unilateral and bilateral pedicle screw fixation offered similar clinical outcome and fusion rate in patients undergoing minimally invasive lumbar interbody fusion surgery. Unilateral and bilateral pedicle screw fixation differed in blood loss and operative time, both of which were significantly reduced in unilateral cohorts.

それが私の患者ケアにどのように影響するか?

It appears that unilateral pedicle screw fixation has the ability to shorten operative time and reduce blood loss while achieving similar clinical outcomes and fusion success to bilateral pedicle screw fixation. The authors acknowledge that the presence of methodological limitations, existence of heterogeneity among studies, and lack of complete data recording weaken the results of this study. Additional high-quality randomized controlled trials with large sample sizes and long-term follow-up are necessary before the wider application of unilateral pedicle screw fixation can be recommended.

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引用方法 ACE Report

OrthoEvidence. Uni- vs bilateral pedicle screw fixation in minimally invasive lumbar interbody fusion. OE Journal. 2015;3(4):38. Available from: https://myorthoevidence.com/AceReport/Show/uni-vs-bilateral-pedicle-screw-fixation-in-minimally-invasive-lumbar-interbody-fusion

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