|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
6 May 2013 |
|
Main ID: |
NCT00509171 |
|
Date of registration:
|
30/07/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism
RIA |
|
Scientific 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 |
|
Date of first enrolment:
|
January 2005 |
|
Target sample size:
|
22 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00509171 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Emil Schemitsch |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
St. Michael's Hospital, Toronto |
|
|
Name:
|
Jeremy A Hall, MD, FRCSC |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
St. Michael's Hospital, Toronto |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Participant aged 16 to 65 years of age
- Skeletally mature
- Isolated, closed femoral shaft fracture (participant may also have sustained a distal
radius/wrist, distal tibia/ankle, hand, and/or foot fractures for eligible inclusion)
- Fracture amenable to an antegrade I.M. nail
- Fracture amenable to insertion of a 12 mm RIA
- Fracture = 48 hrs post injury
- Participant has a 'Thorax' Abbreviated Injury Score (AIS) of < 2
- Participant has a 'Head & Neck' AIS score of < 2
- Provision of informed consent
Exclusion Criteria:
- Fracture proximal to the lesser trochanter
- Open fracture
- Participant has a humeral, tibial, contralateral femoral, spinal,and/or pelvic
fracture
- Pathological fracture
- Fractures > 48 hrs post injury
- Limited life expectancy due to significant medical co-morbidities
- Previous history of esophageal/gastric surgery
- Previous history of esophageal/gastric tumor
- Previous history of esophageal varices
- Medical contraindication to surgery
Age minimum:
16 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Embolism
|
|
Femoral Fractures
|
|
Intervention(s)
|
|
Device: Reamer Irrigator Aspirator
|
|
Primary Outcome(s)
|
|
Extent of intra-operative embolic events.
[Time Frame: Duration of surgical procedure.]
|
|
Secondary Outcome(s)
|
|
Measured pulmonary responses.
[Time Frame: Duration of surgical procedure.]
|
|
Secondary ID(s)
|
|
R-6-30-MAR-07
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|