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

This study has been completed.
Sponsor:
Collaborators:
Orthopaedic Trauma Association
Synthes Inc.
Information provided by (Responsible Party):
Jeremy Hall, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00509171
First received: July 30, 2007
Last updated: April 30, 2013
Last verified: April 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measured pulmonary responses. [ Time Frame: Duration of surgical procedure. ] [ Designated as safety issue: No ]

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
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
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

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jeremy Hall, MD, FRCS(C), St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00509171     History of Changes
Obsolete Identifiers: NCT00753376
Other Study ID Numbers: R-6-30-MAR-07
Study First Received: July 30, 2007
Last Updated: April 30, 2013
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 29, 2014