Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism (RIA)
This study has been completed.
Sponsor:
St. Michael's Hospital, Toronto
Collaborators:
Orthopaedic Trauma Association
Synthes Inc.
Information provided by (Responsible Party):
Jeremy Hall, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00509171
First received: July 30, 2007
Last updated: April 30, 2013
Last verified: April 2013
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 30, 2007 | ||||||||
| Last Updated Date | April 30, 2013 | ||||||||
| Start Date ICMJE | January 2005 | ||||||||
| Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Extent of intra-operative embolic events. [ Time Frame: Duration of surgical procedure. ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Extent of intra-operative embolic events. [ Time Frame: Duration of surgical procedure. ] | ||||||||
| Change History | Complete list of historical versions of study NCT00509171 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Measured pulmonary responses. [ Time Frame: Duration of surgical procedure. ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Measured pulmonary responses. [ Time Frame: Duration of surgical procedure. ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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 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. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Device: Reamer Irrigator Aspirator
Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures |
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 22 | ||||||||
| Completion Date | January 2013 | ||||||||
| Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 16 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00509171 | ||||||||
| Other Study ID Numbers ICMJE | R-6-30-MAR-07 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jeremy Hall, St. Michael's Hospital, Toronto | ||||||||
| Study Sponsor ICMJE | St. Michael's Hospital, Toronto | ||||||||
| Collaborators ICMJE |
|
||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | St. Michael's Hospital, Toronto | ||||||||
| Verification Date | April 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||