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

NCT ID: NCT00327158

Last Updated: 2010-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2010-01-31

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

Conditions

Diaphyseal Femur Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Transesophageal transducer

One time use of reamer during surgery

Intervention Type: PROCEDURE

echocardiography

takes photos of right atrium during the reaming processes

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kentucky

OTHER

Sponsor Role: lead

Responsible Party

UK Orthopaedics

Principal Investigators

William Rosenblum, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky, Department of Orthopaedic Surgery

Jeffrey Selby, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky Department of Orthopaedic Surgery

Locations

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

06-0296-F1V

Identifier Type: -

Identifier Source: org_study_id