Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism — RIA  

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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Embolism
• Embolism, Fat
• Femoral Fractures
• Fractures, Bone

• NCT number: NCT00509171
• Study type: Interventional
• Source: St. Michael's Hospital, Toronto
• Status: Completed
• Phase: N/A
• Start date: January 2005
• Completion date: January 2013