Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Skeletal Versus Cutaneous Traction for Diaphyseal Femur Fractures

Conditions
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Femur Fracture

Intervention / Treatment
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* Procedure: Femoral Traction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cutaneous Traction<br>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<br>* Femoral Traction is a temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation.<br>* Other names: 90-degree Traction;|
| Active Comparator: Skeletal Traction<br>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<br>* Femoral Traction is a temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation.<br>* Other names: 90-degree Traction;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traction, Pre-operative Traction, Proximal Femur Fracture, Femoral Fractures, Femoral Fracture, Skeletal Traction, Cutaneous Traction