Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jesse Even, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00916136
First received: June 5, 2009
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Femur Fracture
Procedure: Femoral Traction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Skeletal Versus Cutaneous Traction for Diaphyseal Femur Fractures

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Difference in the Two Groups in Regards to Resident Time. [ Time Frame: in ED ] [ Designated as safety issue: No ]
    Time from consult entered to time traction apparatus is applied.

  • Time to Pass Guidewire After Attaining Starting Point [ Time Frame: Minutes ] [ Designated as safety issue: No ]
    Time to pass guidewire across reduced fracture once opening reamer is used in OR


Enrollment: 65
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cutaneous Traction
Applied 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.
Procedure: Femoral Traction
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
Active Comparator: Skeletal Traction
A 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.
Procedure: Femoral Traction
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916136

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Jesse L Even, MD Vanderbilt University
  More Information

Publications:
Responsible Party: Jesse Even, Orthopedic Resident, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00916136     History of Changes
Other Study ID Numbers: 081299
Study First Received: June 5, 2009
Results First Received: June 5, 2014
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Pre-operative Traction
Traction
Proximal Femur Fracture
Femoral Fractures
Femoral Fracture
Skeletal Traction
Cutaneous Traction

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 24, 2014