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

Unity Health Toronto22 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Embolism Femoral Fractures

Interventions

Reamer Irrigator AspiratorDEVICE

Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

St. Michael's Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Measurement of Embolic Debris

The differences in total emboli score (Embolism Grading Scal3) between the 2 experimental groups were analyzed with a 2-sample 2-tailed t test. Embolism Grading Scale: Amount: Amount of right atrium fill by echogenic particles none = 0 less than ½ = 1 more than ½ = 2 complete fill = 3 Duration: Duration of echogenesis during 1-minute video segment (seconds) none = 0 less than 5 seconds = 1 5-30 seconds = 2 over 30 seconds = 3 Size: Diameter of largest echogenic particle (mm): none = 0 less than 5mm = 1 5-10mm = 2 larger than 10mm = 3 Percent: 0 =no fill 1. = less than 66 % 2. = greater than 66%

Time frame: Duration of surgical procedure.

Data from ClinicalTrials.gov

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