A Prospective Study to Determine the Effectiveness of Reaming in Reducing Fat Emboli to the Lungs
Primary Purpose
Diaphyseal Femur Fracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transesophageal transducer
echocardiography
Sponsored by
About this trial
This is an interventional treatment trial for Diaphyseal Femur Fracture focused on measuring Reaming, fracture, emboli
Eligibility Criteria
Inclusion Criteria: diaphyseal femur fractures undergoing reamed intramedullary nailing male or female 18 years of age or older Exclusion Criteria: None
Sites / Locations
- University of Kentucky Chandler Medical Center
Outcomes
Primary Outcome Measures
Presence of Emboli
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00327158
Brief Title
A Prospective Study to Determine the Effectiveness of Reaming in Reducing Fat Emboli to the Lungs
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 Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Kentucky
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaphyseal Femur Fracture
Keywords
Reaming, fracture, emboli
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Transesophageal transducer
Intervention Description
One time use of reamer during surgery
Intervention Type
Procedure
Intervention Name(s)
echocardiography
Intervention Description
takes photos of right atrium during the reaming processes
Primary Outcome Measure Information:
Title
Presence of Emboli
Time Frame
Immediately following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diaphyseal femur fractures undergoing reamed intramedullary nailing
male or female
18 years of age or older
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Rosenblum, MD
Organizational Affiliation
University of Kentucky, Department of Orthopaedic Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Selby, MD
Organizational Affiliation
University of Kentucky Department of Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Prospective Study to Determine the Effectiveness of Reaming in Reducing Fat Emboli to the Lungs
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