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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Embolism, Femoral Fractures

Intervention / Treatment
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* Device: Reamer Irrigator Aspirator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1-Standard reamer<br>Standard reamer | Device: Reamer Irrigator Aspirator<br>* Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures<br>|
| Active Comparator: 2-Use of the Reamer-Irrigator Aspirator<br>Use of the Reamer-Irrigator Aspirator | Device: Reamer Irrigator Aspirator<br>* Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 = less than 66 % = greater than 66% | Duration of surgical procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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embolism, femur fracture, lavage, TEE, reamer, IM nail