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Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures

Primary Purpose

Femur Fracture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Femoral Traction
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femur Fracture focused on measuring Pre-operative Traction, Traction, Proximal Femur Fracture, Femoral Fractures, Femoral Fracture, Skeletal Traction, Cutaneous Traction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cutaneous Traction

Skeletal Traction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Difference in the Two Groups in Regards to Resident Time.
Time from consult entered to time traction apparatus is applied.
Time to Pass Guidewire After Attaining Starting Point
Time to pass guidewire across reduced fracture once opening reamer is used in OR

Secondary Outcome Measures

Full Information

First Posted
June 5, 2009
Last Updated
April 27, 2017
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00916136
Brief Title
Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures
Official Title
Evaluation of Skeletal Versus Cutaneous Traction for Diaphyseal Femur Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Fracture
Keywords
Pre-operative Traction, Traction, Proximal Femur Fracture, Femoral Fractures, Femoral Fracture, Skeletal Traction, Cutaneous Traction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cutaneous Traction
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Skeletal Traction
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Femoral Traction
Other Intervention Name(s)
Bucks Traction, Traction Pins, Cutaneous Traction, Skeletal Traction, Skin Traction, Balance Skeletal Traction, Balanced Suspension Traction, (BST), Bryant's Traction, 90-degree Traction
Intervention Description
Femoral Traction is a temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation.
Primary Outcome Measure Information:
Title
Difference in the Two Groups in Regards to Resident Time.
Description
Time from consult entered to time traction apparatus is applied.
Time Frame
while in Emergency Department (ED) up to 24 hours
Title
Time to Pass Guidewire After Attaining Starting Point
Description
Time to pass guidewire across reduced fracture once opening reamer is used in OR
Time Frame
while in Emergency Department (ED) up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse L Even, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16855952
Citation
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.
Results Reference
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Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures

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