Clinical trial NCT00916136: Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures
Official title: Evaluation of Skeletal Versus Cutaneous Traction for Diaphyseal Femur Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femur Fracture
Keywords: Pre-operative Traction
Traction
Proximal Femur Fracture
Femoral Fractures
Femoral Fracture
Skeletal Traction
Cutaneous Traction
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2009-06-09
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference in the Two Groups in Regards to Resident Time.
timeFrame: while in Emergency Department (ED) up to 24 hours
measure: Time to Pass Guidewire After Attaining Starting Point
timeFrame: while in Emergency Department (ED) up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Jesse L Even, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.