TRAUMA
Improve the Efficiency of Surgery for Femoral Shaft Fractures with A Novel Instrument: A Randomized Controlled Trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(21):20 PLoS One. 2016 Apr 26;11(4):e015433268 patients with femoral shaft fractures were randomized to receive either intramedullary nail (IMN) fixation with or without a fracture reduction and guidewire-aiming device. The purpose of this study was to determine if the use of a novel fracture reduction and guide wire aiming instrument was able to improve the operative efficiency of femoral fracture fixation. Findings indicated that a newly designed and manufactured instrument significantly improved the operative time, and decreased the frequency of wire drilling as well as the number of cases requiring open reduction when compared to IMN fixation without the device.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
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。
2/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
Statistics
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 standard treatment of femoral shaft fractures consists of closed reduction and internal fixation with an interlocking intramedullary nail. However, closed reduction can pose a challenge in these fractures, and delays in reduction as well as the need to convert to open reduction impacts the operative time and surgical efficiency in the management of these injuries. Additionally, malreductiion at the fracture may make it difficult to determine the correct guide-wire entry point. While there are several technical tricks and reduction aids used, there has yet to be a device to ease the process of reduction and guide-wire introduction that has been evaluated in a randomized controlled manner. The present study was conducted to determine whether or not a newly manufactured reduction instrument was able to improve the efficiency of intramedullary nail fixation in femoral shaft fractures.
主な研究課題は何ですか？
In the treatment of femoral shaft fractures, does the use of a fracture reduction and guidewire-aiming device during intramedullary nail insertion improve intraoperative efficiency with respect to operative time, operative blood loss, the frequency of guidewire drilling, and the number of cases requiring conversion to open reduction compared to IMN fixation without the device?
重要な知見は？
- Significantly shorter operative time was reported in the IMN+device group compared to the control group (72.71 +/- 6.83 minutes vs. 81.47 +/- 6.11 minutes; p<0.01)
- Significantly lower frequency of starting guide-wire drilling was reported in the IMN+device group compared to the control group (1 vs. 3; p<0.001)
- Significantly lower number of open reduction cases were reported in the IMN+device group compared to the control group (0 vs. 4; p=0.042)
- No significant differences between IMN+device and control groups were reported for operative blood loss (102.65 +/- 16.75 mL vs. 109.21 +/- 17.81 mL, respectively; p=0.123) or duration of hospital stay (6.32 +/- 1.37 days vs. 6.41 +/- 1.4 days; p=0.794)
最も覚えておくべきことは？
In the treatment of femoral shaft fractures, intramedullary nail fixation with the assistance of a fracture reduction and guidewire-aiming device reported significantly improved operative time, the frequency of starting guide-wire drilling, and the number of cases requiring open reduction, in this small, single centre study. However, operative blood loss and duration of hospital stay were similar between groups.
それが私の患者ケアにどのように影響するか？
The results of this study suggest that the use of the novel fracture reduction and guidewire-aiming device to supplement intramedullary nail fixation may be effective in improving operative efficiency compared to intramedullary nail fixation alone. Further research with larger sample sizes and a stricter adherence to protocol is required for higher-quality evidence. Additionally, a multicenter study and an economic evaluation would provide important information with respect to learning curves, generalizability, and cost effectiveness of this novel device.
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