A Prospective Study to Determine the Effectiveness of Reaming in Reducing Fat Emboli to the Lungs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00327158
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : January 28, 2010
Information provided by:
University of Kentucky

Brief Summary:
The purpose of the study is to see if there is a difference in the amount of fat droplets reaching the heart during surgery between the standard reamer currently used and a new reamer system which is expected to reduce the fat going into the blood, via an intraoperative echocardiography done through the food pipe.

Condition or disease Intervention/treatment Phase
Diaphyseal Femur Fracture Procedure: Transesophageal transducer Procedure: echocardiography Not Applicable

Detailed Description:

Reamed intramedullary nailing of diaphyseal femur fractures remains the standard of care for treatment of these fractures. Pressurization of the femoral canal during reaming leads to extra vasations of fat emboli into the systemic circulation, resulting in deposition of fat droplets in the pulmonary vasculature. This phenomenon has been well documented by use of Transesophageal Echocardiography. A novel reaming system has recently become available that may limit this phenomenon. The new reamer system incorporates irrigation and aspiration during reaming, theoretically minimizing pressurization and fat emboli. Additionally, this reamer system allows for one pass reaming as compared to the current system which requires multiple reaming passes.

The objective of this study is to determine effectiveness of reaming in diminishing fat emboli to the lungs as evidenced by decreased numbers of large fat droplets entering the right heart as measured by transesophageal echocardiography during the reaming process. This will determine if there is a benefit to aspiration during reaming as would be expected.

During the reaming process a transesophageal echo cardiogram will be performed to analyze the presence or absence of emboli and the mean regarding the total time that each of the embolic grades is present during each of the intervals across the patient groups

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using Transesophageal Echocardiography To Assess Fat Emboli As A Result Of Reaming In A Prospective Randomized Control Trial To Determine The Effectiveness Of Reaming In Diminishing Fat Emboli To The Lungs
Study Start Date : May 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Intervention Details:
  • Procedure: Transesophageal transducer
    One time use of reamer during surgery
  • Procedure: echocardiography
    takes photos of right atrium during the reaming processes

Primary Outcome Measures :
  1. Presence of Emboli [ Time Frame: Immediately following surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diaphyseal femur fractures undergoing reamed intramedullary nailing
  • male or female
  • 18 years of age or older

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00327158

United States, Kentucky
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Principal Investigator: William Rosenblum, MD University of Kentucky, Department of Orthopaedic Surgery
Principal Investigator: Jeffrey Selby, MD University of Kentucky Department of Orthopaedic Surgery

Responsible Party: Jeffrey Selby, UK Orthopaedics Identifier: NCT00327158     History of Changes
Other Study ID Numbers: 06-0296-F1V
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2010

Keywords provided by University of Kentucky:

Additional relevant MeSH terms:
Femoral Fractures
Embolism, Fat
Fractures, Bone
Wounds and Injuries
Leg Injuries
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases