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

Primary Purpose

Embolism, Femoral Fractures

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Reamer Irrigator Aspirator
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Embolism focused on measuring embolism, femur fracture, lavage, TEE, reamer, IM nail

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1-Standard reamer

2-Use of the Reamer-Irrigator Aspirator

Arm Description

Standard reamer

Use of the Reamer-Irrigator Aspirator

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

Full Information

First Posted
July 30, 2007
Last Updated
May 6, 2020
Sponsor
Unity Health Toronto
Collaborators
Orthopaedic Trauma Association, Synthes Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00509171
Brief Title
Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Orthopaedic Trauma Association, Synthes Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embolism, Femoral Fractures
Keywords
embolism, femur fracture, lavage, TEE, reamer, IM nail

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1-Standard reamer
Arm Type
Active Comparator
Arm Description
Standard reamer
Arm Title
2-Use of the Reamer-Irrigator Aspirator
Arm Type
Active Comparator
Arm Description
Use of the Reamer-Irrigator Aspirator
Intervention Type
Device
Intervention Name(s)
Reamer Irrigator Aspirator
Intervention Description
Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
Primary Outcome Measure Information:
Title
Measurement of Embolic Debris
Description
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%
Time Frame
Duration of surgical procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy A Hall, MD, FRCSC
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emil Schemitsch
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 1R6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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