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Fracture reduction/guidewire-aiming device effective with IMN in femoral shaft fracture

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Fracture reduction/guidewire-aiming device effective with IMN in femoral shaft fracture

Vol: 5| Issue: 11| Number:1| ISSN#: 2564-2537
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

Improve the Efficiency of Surgery for Femoral Shaft Fractures with A Novel Instrument: A Randomized Controlled Trial

PLoS One. 2016 Apr 26;11(4):e0154332

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Synopsis

68 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.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Shanghai Municipal Commission of Health and Family Planning
Conflicts:
None disclosed

Risk of Bias

5/10

Reporting Criteria

15/20

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

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

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?

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.

What was the principal research question?

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?

Study Characteristics -
Population:
68 patients, over 60 years of age, with a femoral shaft fracture, were included. Eligible patients had a unilateral, traumatic, closed fracture with complete displacement at the fracture site, with no or simple comminution (AO/OTA 32.A or 32.B fracture patterns), that underwent surgical treatment within 7 days of the injury. Open fractures, bilateral fractures, and/or pathological fractures were excluded.
Intervention:
IMN+device group: Patients underwent closed reduction and antegrade intramedullary nail fixation with the assistance of the fracture reduction and guidewire-aiming device. The fracture reduction device consists of 2 adjustable bone clamps (each with 2 independent tong arms that lock to each other once passed around the femoral shaft), 2 connectors and a long bar. Each clamp is placed percutaneously through a small lateral incision, with one clamp proximal and the other distal to the fracture site. The clamps are then linked to a long bar using connectors, which allow traction to be applied and alignment to be corrected in multiple planes. The guidewire-aiming device consists of a column, calibrated tube, slider and short sleeve. The column and slider are connected to the proximal bone clamp, which is subsequently connected to a calibrated bar and short sleeve. The calibrated bar and sleeve can be passed through and incision just proximal to the greater trochanter, and adjusted to have the sleeve coincide with the correct start point relative to the tip of the greater trochanter. This can then be locked into place to facilitate the starting guidewire placement. (n=34, 34 completed follow-up; Mean age: 37.32 +/- 8.40; 23M/11F)
Comparison:
Control group: Patients underwent closed reduction and antegrade intramedullary nail internal fixation without the novel fracture reduction and guide-wire aiming device. (n=34, 34 completed follow-up; Mean age: 35.12 +/- 9.34; 20M/14F)
Outcomes:
Outcomes included operative time, operative blood loss, the frequency of guidewire drilling, the number of cases requiring open reduction, and hospital stay duration. The incidence of adverse events was also documented.
Methods:
RCT
Time:
Clinical and radiological outcomes were followed-up at 1 day, and 1, 3, 6, 9, and 12 months postoperatively.

What were the important findings?

  • 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)

What should I remember most?

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.

How will this affect the care of my patients?

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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