Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures

NCT ID: NCT00916136

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-12-31

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.

Conditions

Femur Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Femoral Traction

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Femoral Traction

Intervention Type: PROCEDURE

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

Interventions

Femoral Traction

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

Intervention Type: PROCEDURE

Other Intervention Names

Bucks Traction; Traction Pins; Cutaneous Traction; Skeletal Traction; Skin Traction; Balance Skeletal Traction; Balanced Suspension Traction; (BST); Bryant's Traction; 90-degree Traction

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesse L Even, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16855952 (View on PubMed)

Other Identifiers

081299

Identifier Type: -

Identifier Source: org_study_id