Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures

Femur Fracture Clinical Trial

Official title:

Evaluation of Skeletal Versus Cutaneous Traction for Diaphyseal Femur Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916136
• Other study ID #: 081299
• Status: Completed
• Phase: N/A
• First received: June 5, 2009
• Last updated: June 5, 2014
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

Procedure:
• Femoral Traction
Temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Parker MJ, Handoll HH. Pre-operative traction for fractures of the proximal femur in adults. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD000168. Review. Update in: Cochrane Database Syst Rev. 2011;(12):CD000168. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the Two Groups in Regards to Resident Time.	Time from consult entered to time traction apparatus is applied.	in ED	No
Primary	Time to Pass Guidewire After Attaining Starting Point	Time to pass guidewire across reduced fracture once opening reamer is used in OR	Minutes	No