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

Femoral Fractures Clinical Trial

— RIA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509171
• Other study ID #: R-6-30-MAR-07
• Status: Completed
• Phase: N/A
• Start date: January 2005
• Est. completion date: January 2013

Study information

• Verified date: May 2020
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Other known NCT identifiers

• NCT00753376

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

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

Related Conditions & MeSH terms

• Embolism
• Embolism, Fat
• Femoral Fractures
• Fractures, Bone

Intervention

Device:
• Reamer Irrigator Aspirator
Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Orthopaedic Trauma Association, Synthes Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.