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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00509171
First Posted: July 31, 2007
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Orthopaedic Trauma Association
Synthes Inc.
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
  Purpose
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

Condition Intervention
Embolism Femoral Fractures Device: Reamer Irrigator Aspirator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Extent of intra-operative embolic events. [ Time Frame: Duration of surgical procedure. ]

Secondary Outcome Measures:
  • Measured pulmonary responses. [ Time Frame: Duration of surgical procedure. ]

Enrollment: 22
Study Start Date: January 2005
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1-Standard reamer
Standard reamer
Device: Reamer Irrigator Aspirator
Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
Active Comparator: 2-Use of the Reamer-Irrigator Aspirator
Use of the Reamer-Irrigator Aspirator
Device: Reamer Irrigator Aspirator
Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509171


Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 1R6
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Orthopaedic Trauma Association
Synthes Inc.
Investigators
Principal Investigator: Jeremy A Hall, MD, FRCSC St. Michael's Hospital, Toronto
Principal Investigator: Emil Schemitsch St. Michael's Hospital, Toronto
  More Information

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00509171     History of Changes
Obsolete Identifiers: NCT00753376
Other Study ID Numbers: R-6-30-MAR-07
First Submitted: July 30, 2007
First Posted: July 31, 2007
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St. Michael's Hospital, Toronto:
embolism
femur fracture
lavage
TEE
reamer
IM nail

Additional relevant MeSH terms:
Fractures, Bone
Embolism
Femoral Fractures
Embolism, Fat
Wounds and Injuries
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Leg Injuries