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Volume:2 Issue:7 Number:533 ISSN#:2563-5476
RCT
ACE Report #3620

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


How to Cite

OrthoEvidence. No advantage of unreamed intramedullary nailing over reamed nailing for femoral fractures. ACE Report. 2013;2(7):533. Available from: https://myorthoevidence.com/AceReport/Report/3620

Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

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

J Trauma. 2006 Nov;61(5):1178-85

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Synopsis

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.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
EVO-grant from the state of Finland
Conflicts:
None disclosed

Risk of Bias

6/10

Reporting Criteria

12/20

Fragility Index

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)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

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

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

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.

What was the principal research question?

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?

Study Characteristics -
Population:
18 patients with unilateral, closed, (AO type 32 A-C) femoral shaft fractures
Intervention:
Unreamed group: unreamed intramedullary nailing (Synthes AO, Paoli, Penn.) (n=9)
Comparison:
Reamed group: reamed intramedullary nailing (Synthes AO, Paoli, Penn.) (n=9)
Outcomes:
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).
Methods:
RCT: prospective; Surgeons were not blinded (blinding of patients or assessors was not reported)
Time:
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.

What were the important findings?

  • 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)

What should I remember most?

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.

How will this affect the care of my patients?

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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