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

This study has been completed.
Sponsor:
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00327158
First received: May 16, 2006
Last updated: January 27, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention
Diaphyseal Femur Fracture
 Procedure: Transesophageal transducer
Procedure: echocardiography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Presence of Emboli [ Time Frame: Immediately following surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: May 2006
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Transesophageal transducer
    One time use of reamer during surgery
    Procedure: echocardiography
    takes photos of right atrium during the reaming processes
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327158

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

No publications provided

Responsible Party: Jeffrey Selby, UK Orthopaedics
ClinicalTrials.gov Identifier: NCT00327158     History of Changes
Other Study ID Numbers: 06-0296-F1V
Study First Received: May 16, 2006
Last Updated: January 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Reaming
fracture
emboli

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

ClinicalTrials.gov processed this record on June 17, 2013