N/A
N=22
Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism
Embolism · Femoral Fractures
Bottom Line
View on ClinicalTrials.gov: NCT00509171 ↗Enrolled (actual)
22
Serious AEs
18.2%
Results posted
May 2020
Primary outcome: Primary: Measurement of Embolic Debris — 5.3; 4.05 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reamer Irrigator Aspirator (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Unity Health Toronto
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Embolic Debris |
5.3; 4.05 | — |
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
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00509171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.