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

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1-Standard reamer	Reamer Irrigator Aspirator	Standard reamer
2-Use of the Reamer-Irrigator Aspirator	Reamer Irrigator Aspirator	Use of the Reamer-Irrigator Aspirator

Primary Outcome Measures

Name	Time	Method
Measurement of Embolic Debris	Duration of surgical procedure.	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%