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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Intramedulla

Brief 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 Summary:

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.

Sponsor: St. Michael's Hospital, Toronto

Current Primary Outcome: Extent of intra-operative embolic events. [ Time Frame: Duration of surgical procedure. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Measured pulmonary responses. [ Time Frame: Duration of surgical procedure. ]

Original Secondary Outcome: Same as current

Information By: St. Michael's Hospital, Toronto

Dates:
Date Received: July 30, 2007
Date Started: January 2005
Date Completion:
Last Updated: December 6, 2016
Last Verified: December 2016