Diaphyseal Femur Fracture Clinical Trial
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
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment