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No advantage of unreamed intramedullary nailing over reamed nailing for femoral fractures
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TRAUMA

Similar Central Hemodynamics but Increased Postoperative Oxygen Consumption in Unreamed Versus Reamed Intramedullary Nailing of Femoral Fractures

OrthoEvidence Journal (OE Journal) - ACE Report

OE Journal. 2013;1(12):256 J Trauma. 2006 Nov;61(5):1178-85

18 patients with unilateral femoral shaft fractures were randomized to receive reamed or unreamed intramedullary nailing to determine if there are acute differences in cardiopulmonary variables between these techniques. Patients were monitored pre-operatively, peri-operatively and 16-20 hours post-operatively with radial artery and pulmonary artery catheters. Prior to the operation, both groups demonstrated higher than normal pulmonary shunt fractions. 16-20 hours after the operation, the mixed venous oxygen saturation was lower in the unreamed group than in the reamed group, while the oxygen consumption index was higher in the unreamed group than in the reamed group. The two groups did not differ significantly in any other cardiopulmonary variable.


出版資金提供の詳細 +
資金提供:
Non-Industry funded
スポンサー:
EVO-grant from the state of Finland
コンフリクト:
None disclosed

バイアスのリスク

6/10

報告基準

12/20

脆弱性指数

N/A

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

3/4

Outcome Measurements

0/4

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?

There has been some debate about the effectiveness of intramedullary nailing of femoral shaft fractures using the reamed versus the unreamed technique. Past research has suggested that unreamed nailing lowers the risk of adverse pulmonary side effects, whereas other research has concluded that the two techniques do not result in significant differences regarding the occurrence of pulmonary events. This study aimed to determine which technique is superior in terms of cardiopulmonary variables, as well as to investigate the time points over the course of the study in which the heart is under most strain.

主な研究課題は何ですか?

Does unreamed intramedullary nailing outperform reamed nailing in terms of cardiopulmonary variables assessed pre-operatively, peri-operatively, and post-operatively for 16-20 hours in patients with unilateral femoral shaft fractures? Additionally, at which points of time over the course of the study is the heart under most strain?

研究の特徴 +
人口:
18 patients with unilateral, closed, (AO type 32 A-C) femoral shaft fractures
介入:
Unreamed group: unreamed intramedullary nailing (Synthes AO, Paoli, Penn.) (n=9)
比較:
Reamed group: reamed intramedullary nailing (Synthes AO, Paoli, Penn.) (n=9)
アウトカム:
Blood gas tensions, hemoglobin oxygen saturations, peripheral arterial and mixed venous oxygen saturations were recorded. The hemodynamic pressures were also monitored (mean systemic arterial pressure [MAP], the corresponding pulmonary arterial and wedged pressures [PAPM, PCWP] and central venous pressure [CVP]). Cardiac output and right ventricular ejection fraction (REF) were measured. Lastly, Hemodynamic and oxygenation parameters were calculated, including cardiac index (CI), RV end-systolic volume index (ESVI), RV end-diastolic volume index (EDVI), systemic and pulmonary resistance indexes (SVRI, PVRI), left and right ventricular stroke work indexes (LVSWI, RVSWI), oxygen consumption index (VO2I), and pulmonary shunt fraction (Qs/Qt).
方法:
RCT: prospective; Surgeons were not blinded (blinding of patients or assessors was not reported)
時間:
Assessments were made pre-operatively at 0.5 to 1 hour before anaesthesia was given, peri-operatively 30 minutes after induction of anaesthesia, at the timepoint when nailing was completed, when the patient was under stable general anaesthesia, 1 hour post-surgery when the patient was awake, and 16-20 hours post-surgery when the patient was awake.

重要な知見は?

  • Prior to the operation, both groups demonstrated a pulmonary shunt fraction (Qs/Qt) that was more than 3 times greater than normal (reamed: 23 +/- 12%; unreamed: 27 +/- 11%); the difference between the two groups was not significant
  • At 16-20 hours post-operation, the mixed venous oxygen saturation was lower in the unreamed group (65 +/- 8) than in the reamed group (70 +/- 5; p<0.05)
  • After 16-20 hours post-surgery, VO2I was significantly higher in the unreamed group (186 +/- 21 mL/min/m^2) than in the reamed group (151 +/- 20 mL/min/m^2; p<0.05)
  • The two groups did not differ significantly in any of the other cardiopulmonary variables (p>0.05)
  • The most strenuous time period for the heart was when the patient was under stable general anaesthesia (immediately after closure of the wound) (CI, and right and left ventricular volume stroke work indices were highest at this point) and when the patient was awake 1 hour after surgery (at this time, heart rate was increased, and RVSWI and CI were higher than normal)
最も覚えておくべきことは?

Although several abnormal cardiopulmonary values were seen in both groups, there were no significant differences between the reamed and the unreamed femoral nails. Results from this study also suggest that the most strenuous time periods for the heart are immediately after surgery when the wound has been closed, and around 1 hour after surgery.

それが私の患者ケアにどのように影響するか?

Patients with unilateral femoral shaft fractures experience similar outcomes regardless of the use of the reamed or unreamed intramedullary nailing technique. Since both groups displayed significantly abnormal cardiopulmonary variables in the study, invasive monitoring for patients with problematic pre-operative oxygenation and high risk cardiac patients may be advisable.

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引用方法 ACE Report

OrthoEvidence. No advantage of unreamed intramedullary nailing over reamed nailing for femoral fractures. OE Journal. 2013;1(12):256. Available from: https://myorthoevidence.com/AceReport/Show/

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