TRAUMA
Operative versus nonoperative care of displaced midshaft clavicular fractures: a meta-analysis of randomized clinical trials
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(12):58 J Bone Joint Surg Am. 2012 Apr 18;94(8):675-84This meta-analysis identified 6 randomized clinical trials that compared operative and non-operative treatment of acute, displaced mid-shaft clavicle fractures. Results from this analysis indicate that there was a reduced complication rate in the operatively treated patients, with a decrease in non-unions and symptomatic malunions. A greater number of patients treated operatively were able to return to moderate activity 16 days following the injury, demonstrating that operative treatment provides superior early outcomes.
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？
The non-union rate of acute, displaced mid shaft fractures treated non-operatively has been reported to be as high as 15-20% and has detrimental effects on shoulder muscle strength. Based on these suboptimal outcomes for non-operative management, primary operative care has increased in popularity. The meta-analysis was conducted to evaluate treatment effects, potential harm and patient outcomes of these differing methods.
主な研究課題は何ですか？
Which treatment, operative or nonoperative, provides the best clinical and functional results, and what are the complications associated with these procedures for patients presenting with displaced mid-shaft fracture of the clavicle?
重要な知見は？
- Non-union rate was significantly higher in the non-operative patients (29/200), than in the patients treated operatively (3/212) (p=0.001)
- The rate of patients with a symptomatic malunion was signficantly greater in the non-operative group (17/200), compared to the operative group (0/200) (p<0.001)
- The overall complication rate was significantly greater in the non-operative group (84/200), compared to the operative group (62/212) (p=0.0075)
- Three studies reported Constant Shoulder scores at one year weighted operative average was 94.3 compared to the non-operative average of 90.2
- DASH scores appeared to favor the operative group, but only reported numerically in 2 studies and graphically in one
- Early return to moderate activity on the 16th day was possible in 80% of the operatively treated patients, compared to 55% in the non-operative patients
最も覚えておくべきことは？
The results from this meta-analysis indicate that operative treatment of acute, displaced mid-shaft fractures of the clavicle provides a reduced rate of complication with fewer patients suffering non-union or symptomatic malunions. A greater number of operatively treated patients also were able to return to function earlier than the conservative treatment.
それが私の患者ケアにどのように影響するか？
The results from this meta-analysis support the use of primary operative treatment of acute, displaced mid shaft fractures of the clavicle.
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