NCT00509171

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Embolism
• Femoral Fractures

Interventions

Type	Name	Description
DEVICE	Reamer Irrigator Aspirator	Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures

Timeline

• Start date: 2005-01-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2007-07-31
• Last updated: 2020-05-14
• Results posted: 2020-05-07

Locations

1 site across 1 country: Canada