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| Sponsors and Collaborators: |
St. Michael's Hospital, Toronto Orthopaedic Trauma Association Synthes Inc. |
|---|---|
| Information provided by: | St. Michael's Hospital, Toronto |
| ClinicalTrials.gov Identifier: | NCT00509171 |
Purpose
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
| Condition | Intervention |
|---|---|
|
Embolism Femoral Fractures |
Device: Reamer Irrigator Aspirator |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 46 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Standard reamer
|
Device: Reamer Irrigator Aspirator
Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
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2: Active Comparator
Use of the Reamer-Irrigator Aspirator
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Device: Reamer Irrigator Aspirator
Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
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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.
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Milena R Vicente, RN | 416-864-6060 ext 2608 | vicentem@smh.toronto.on.ca |
| Contact: Lisa M Wild, RN, MN, ACNP | 416-864-6060 ext 2713 | wildl@smh.toronto.on.ca |
| Canada, Ontario | |
| St. Michael's Hospital | Recruiting |
| Toronto, Ontario, Canada, M5C 1R6 | |
| Principal Investigator: Emil H Schemitsch, MD, FRCSC | |
| Sub-Investigator: Michael D McKee, MD, FRCSC | |
| Principal Investigator: | Emil H Schemitsch, MD, FRCSC | St. Michael's Hospital, Toronto |
More Information
| Responsible Party: | St.MIchael's Hospital ( Emil Schemitsch, MD, FRCSC ) |
| Study ID Numbers: | R-6-30-MAR-07 |
| Study First Received: | July 30, 2007 |
| Last Updated: | July 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00509171 |
| Health Authority: | Canada: Health Canada |
|
embolism femur fracture lavage |
TEE reamer IM nail |
|
Embolism and Thrombosis Femoral Fractures Embolism Fractures, Bone Wounds and Injuries |
Vascular Diseases Embolism, Fat Disorders of Environmental Origin Leg Injuries Thrombosis |
|
Cardiovascular Diseases |
