No advantage of unreamed intramedullary nailing over reamed nailing for femoral fractures .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(12):256 J Trauma. 2006 Nov;61(5):1178-8518 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.
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)?
Ja = 1
Ungewiss = 0.5
Nicht relevant = 0
Nein = 0
Die Bewertung der Berichtskriterien bewertet die Transparenz, mit der die Autoren die methodischen und studienspezifischen Merkmale der Studie in der Veröffentlichung angeben. Die Bewertung ist in fünf Kategorien unterteilt, die im Folgenden vorgestellt werden.
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
Der Fragilitätsindex ist ein Instrument, das bei der Interpretation signifikanter Ergebnisse hilft und ein Maß für die Stärke eines Ergebnisses liefert. Der Fragilitätsindex gibt die Anzahl der aufeinanderfolgenden Ereignisse an, die zu einem dichotomen Ergebnis hinzugefügt werden müssen, damit das Ergebnis nicht mehr signifikant ist. Eine kleine Zahl steht für ein schwächeres Ergebnis und eine große Zahl für ein stärkeres Ergebnis.
Warum wurde diese Studie jetzt benötigt?
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.
Was war die wichtigste Forschungsfrage?
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?
- 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)
Was sollte ich mir besonders merken?
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.
Wie wird sich dies auf die Behandlung meiner Patienten auswirken?
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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