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

NCT ID: NCT00509171

Last Updated: 2020-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2013-01-31

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.

Conditions

Embolism; Femoral Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1-Standard reamer

Standard reamer

Group Type: ACTIVE_COMPARATOR

Reamer Irrigator Aspirator

Intervention Type: DEVICE

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

2-Use of the Reamer-Irrigator Aspirator

Use of the Reamer-Irrigator Aspirator

Group Type: ACTIVE_COMPARATOR

Reamer Irrigator Aspirator

Intervention Type: DEVICE

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

Interventions

Reamer Irrigator Aspirator

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Orthopaedic Trauma Association

OTHER

Sponsor Role: collaborator

Synthes Inc.

INDUSTRY

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy A Hall, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Emil Schemitsch

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

R-6-30-MAR-07

Identifier Type: -

Identifier Source: org_study_id

NCT00753376

Identifier Type: -

Identifier Source: nct_alias