Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures

Evaluation of Skeletal Versus Cutaneous Traction for Diaphyseal 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.

Study Overview

• Status: Completed
• Conditions: Femur Fracture
• Intervention / Treatment: Procedure: Femoral 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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the Two Groups in Regards to Resident Time.	Time from consult entered to time traction apparatus is applied.	while in Emergency Department (ED) up to 24 hours
Time to Pass Guidewire After Attaining Starting Point	Time to pass guidewire across reduced fracture once opening reamer is used in OR	while in Emergency Department (ED) up to 24 hours

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Jesse L Even, MD, Vanderbilt University

Publications and helpful links

General Publications

• Parker MJ, Handoll HH. Pre-operative traction for fractures of the proximal femur in adults. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD000168. doi: 10.1002/14651858.CD000168.pub2.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: June 5, 2009
• First Submitted That Met QC Criteria: June 5, 2009
• First Posted (Estimate): June 9, 2009

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Traction; Femoral Fractures; Pre-operative Traction; Proximal Femur Fracture; Femoral Fracture; Skeletal Traction; Cutaneous Traction
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: 081299