Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism (RIA)

Unity Health Toronto

Status: Completed

Conditions: Embolism; Femoral Fractures

Treatments: Device: Reamer Irrigator Aspirator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00509171

R-6-30-MAR-07

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

1-Standard reamer

Active Comparator group

Description:

Standard reamer

Treatment:

Device: Reamer Irrigator Aspirator

2-Use of the Reamer-Irrigator Aspirator

Active Comparator group

Description:

Use of the Reamer-Irrigator Aspirator

Treatment:

Device: Reamer Irrigator Aspirator