Clinical trial NCT00509171: Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embolism
Femoral Fractures
Keywords: embolism
femur fracture
lavage
TEE
reamer
IM nail
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
name: Synthes Inc.
First posted: 2007-07-31
Enrollment: 22
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \< 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

Primary outcomes:
measure: Measurement of Embolic Debris
timeFrame: Duration of surgical procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Jeremy A Hall, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Emil Schemitsch
role: PRINCIPAL_INVESTIGATOR
References: