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Completed

NCT Number: NCT00916136

Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femoral Traction

Procedure

Femoral Traction is a temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation.

Other names: Bucks Traction, Traction Pins, Cutaneous Traction, Skeletal Traction, Skin Traction, Balance Skeletal Traction, Balanced Suspension Traction, (BST), Bryant's Traction, 90-degree Traction

Primary outcomes

  1. Difference in the Two Groups in Regards to Resident Time.

    Time frame: while in Emergency Department (ED) up to 24 hours

    Time from consult entered to time traction apparatus is applied.

  2. Time to Pass Guidewire After Attaining Starting Point

    Time frame: while in Emergency Department (ED) up to 24 hours

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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Evaluation of Skeletal Versus Cutaneous Traction for Diaphyseal Femur Fractures

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 9, 2009
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.