TRAUMA
Intramedullary Nail versus Dynamic Compression Plate Fixation in Treating Humeral Shaft Fractures: Grading the Evidence through a Meta-Analysis
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(7):38 PLoS One. 2013 Dec 16;8(12):e82075. doi: 10.1371/journal.pone.008207510 studies (8 randomized and 2 quasi-randomized controlled trials) were included in this analysis comparing intramedullary nails and dynamic compression plates in the treatment of humeral shaft fractures. The results indicated that while fracture union, functional outcome, and rates of radial nerve injury and infection were similar between treatments, intramedullary nails were associated with higher incidences of intraoperative fracture communition, shoulder impingement, restricted range of motion, implant failure, and re-operation. The strength of these findings were limited by the low quality of evidence, as evaluated using the GRADE system.
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。
3/4
Introduction
4/4
Accessing Data
3/4
Analysing Data
4/4
Results
2/4
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？
Humeral shaft fractures represent a common site of traumatic injury, accounting for up to 3% of all fractures. While most elect to manage these conservatively, surgical intervention is often required in cases of complicated fractures. There are two current standout treatment options: intramedullary nailing or dynamic compression plating. However, there has been continuous debate over whether one option represents a superior method of treatment.
主な研究課題は何ですか？
Is intramedullary nailing (IMN) or dynamic compression plating (DCP) superior in the surgical treatment of humeral shaft fractures?
重要な知見は？
- A total of 10 studies met the criteria for inclusion; 8 randomized controlled trials and 2 quasi-randomized controlled trials. A total of 448 patients were included among the 10 publications.
- Meta-analysis of all 10 studies indicated no significant difference between IMN and DCP regarding fracture union (RR 0.96 (95%CI 0.90, 1.02)) (p=0.19).
- Among 3 studies, there was no significant difference between IMN and DCP in outcome on the American Shoulder and Elbow Surgeons (ASES) score (WMD -1.84 (95%CI -3.91, 0.22)) (p=0.08).
- Pooling of incidence of iatrogenic radial nerve injury from all 10 studies indicated no significant difference between IMN and DCP (RR 0.72 (95%CI 0.35, 1.47)) (p=0.37).
- Meta-analysis of 6 studies indicated that the incidence of intraoperative communition of the fracture was significantly higher with IMN compared with DCP (RR 3.14 (95%CI 1.02, 9.64)) (p=0.05).
- Pooled results from 9 included studies demonstrated no significant difference between IMN and DCP regarding incidence of infection (RR 0.48 (95%CI 0.19, 1.24)) (p=0.13).
- Pooled data from 7 studies indicated a significantly higher incidence of shoulder impingement with IMN compared to DCP (RR 7.32 (95%CI 2.64, 20.29)) (p=0.0001). Meta-analysis of 4 studies indicated a significantly higher risk of restricted shoulder ROM with IMN compared to DCP (RR 9.27 (95%CI 2.22, 38.72)) (p=0.002).
- The rate of implant failure was significantly higher with IMN compared to DCP (7 studies; RR 3.23 (95%CI 1.15, 9.06)) (p=0.03). The incidence of re-operation was also significantly higher with IMN compared to DCP (9 studies; RR 2.21 (95%CI 1.28, 3.81)) (p=0.005).
- The overall quality of evidence, as evaluated by the GRADE system, was judged to be very low. All studies were determined to have unclear or high risk of bias regarding allocation concealment (selection bias), participant and personnel blinding (performance bias), and assessor blinding (detection bias).
最も覚えておくべきことは？
Analyses comparing intramedullary nailing and dynamic compression plating for humeral shaft fractures indicated that there was no significant difference between treatments for fracture union, functional outcome on the ASES, and incidences of radial nerve damage and infection. Intramedullary nailing was associated with higher risks of intraoperative communition, shoulder impingement, restricted ROM, implant failure, and re-operation. The low quality of evidence provided by the included studies limited the strength of these findings.
それが私の患者ケアにどのように影響するか？
The results of this analysis suggest that dynamic compression plating may be more advantageous in surgical intervention of humeral shaft fractures. Due the unclear or high risk of bias associated with the included studies, additional, methodologically sound randomized controlled trials are warranted for future comparisons between intramedullary nails and dynamic compression plates.
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