Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures

Vanderbilt University Medical Center

Status: Completed

Conditions: Femur Fracture

Treatments: Procedure: Femoral Traction

Study type: Interventional

Funder types: Other

Identifiers

NCT00916136

081299

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Cutaneous Traction

Active Comparator group

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.

Treatment:

Procedure: Femoral Traction

Skeletal Traction

Active Comparator group

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.

Treatment:

Procedure: Femoral Traction