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Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures

Not Applicable
Completed
Conditions
Femur Fracture
Interventions
Procedure: Femoral Traction
Registration Number
NCT00916136
Lead Sponsor
Vanderbilt University Medical Center
Brief Summary

The purpose of this study is to determine whether there are any differences in skeletal or cutaneous traction for the treatment of femur fractures.

Detailed Description

Diaphyseal femur fractures are a common occurrence in busy level one trauma centers and even in the age of damage control orthopaedics most of these fractures are fixed definitively within 24 hours. The historical method of temporizing these fractures has been to place a distal femoral or proximal tibial skeletal traction pin. However, in the pediatric population skeletal traction is not utilized due to concern for physeal injury and cutaneous traction has been the gold standard for decades. Reasons for skeletal traction in adults are not well defined and there are no clinical studies showing that skeletal traction provides better outcomes in time of reduction in the operating theater or better pain control than cutaneous traction. With the ever increasing amount of high energy trauma seen by junior residents in the emergency department time constraints have become a large factor in patient care. Long delays for sedation and equipment procurement make stabilizing a diaphyseal femur fracture a time consuming experience. The purpose of this study is to determine whether differences exist between skeletal and cutaneous femoral traction in terms of: 1) time in patient consultation and fracture stabilization; 2) cost and risk to the patient due to lack of conscious sedation; 3) pain scores prior to surgery; 4) time of reduction of the diaphyseal femur fraction during surgical fixation; and 5) pain relief after traction application.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
66
Inclusion Criteria
  • Patient willing to consent
  • 18 years of age or older
  • Sustained a diaphyseal femur fracture, open or closed
  • English competent
  • Isolated fracture on that extremity
Exclusion Criteria
  • Pathologic fracture
  • Sedated patient
  • Polytrauma to same extremity
  • Unable or not willing to consent

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Skeletal TractionFemoral TractionA small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
Cutaneous TractionFemoral TractionApplied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
Primary Outcome Measures
NameTimeMethod
Time to Pass Guidewire After Attaining Starting Pointwhile in Emergency Department (ED) up to 24 hours

Time to pass guidewire across reduced fracture once opening reamer is used in OR

Difference in the Two Groups in Regards to Resident Time.while in Emergency Department (ED) up to 24 hours

Time from consult entered to time traction apparatus is applied.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

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