Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures

NCT00916136 | Completed Results

• 1 other identifier: 081299
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Femur Fracture

Keywords

Pre-operative Traction; Traction; Proximal Femur Fracture; Femoral Fractures; Femoral Fracture; Skeletal Traction; Cutaneous Traction

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cutaneous Traction

ACTIVE COMPARATOR

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

Skeletal Traction

ACTIVE COMPARATOR

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

Interventions

Femoral Traction PROCEDURE

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

Also known as: Bucks Traction, Traction Pins, Cutaneous Traction, Skeletal Traction, Skin Traction, Balance Skeletal Traction, Balanced Suspension Traction, (BST), Bryant's Traction, 90-degree Traction

Cutaneous Traction; Skeletal Traction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient willing to consent
• years of age or older
• Sustained a diaphyseal femur fracture, open or closed
• English competent
• Isolated fracture on that extremity

You may not qualify if:

• Pathologic fracture
• Sedated patient
• Polytrauma to same extremity
• Unable or not willing to consent

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related 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. doi: 10.1002/14651858.CD000168.pub2.

  PMID: 16855952 BACKGROUND

MeSH Terms

Conditions

Femoral Fractures; Proximal Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Neck Fractures; Hip Fractures; Hip Injuries

Results Point of Contact

• Title: William Obremskey MD MPH
• Organization: Vanderbilt

william.obremskey@vanderbilt.edu

615-936-0112

Study Officials

• Jesse L Even, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 9, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 30, 2017
• Results First Posted: July 8, 2014

Record last verified: 2017-04

Locations

US (1)