Femoral Fractures Clinical Trial
Official title:
A Prospective Randomized Trial Investigating the Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism and Respiratory Function During Intramedullary Nailing of Femoral Shaft Fractures
The purpose of this study is to determine the effect on the incidence of fat emboli when using a Reamer-Irrigator Aspirator during reamed IM nail fixation of femoral shaft fractures
The current practice of reaming the medullary canal for the fixation of femur fractures is
recommended, however, there is an associated increase in the level of embolic events which
confers morbidity and, occasionally, mortality.
The RIA is a single device which is able to ream the medullary canal, irrigate the canal and
subsequently aspirate the reamed medullary contents in order to get rid of medullary fat and
other contents responsible for these adverse embolic events.
A novel Reamer-Irrigator-Aspirator (RIA) (Synthes, Inc) will be evaluated in a randomized
study, to determine its effect on the incidence of fat emboli events during reamed IM nail
fixation of consecutive femoral shaft fractures as measured by intra-operative
transesophageal echocardiogram and pulmonary function.
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