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Incidence of Fat Embolism With Computer Assisted Total Knee Arthroplasty (Fat Embolism)

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ClinicalTrials.gov Identifier: NCT00656877
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : April 11, 2008
Sponsor:
Information provided by:
Marshall University

Brief Summary:
The study to determine the if the incidence of Fat Embolism is decreased using Computer Assisted technology when performing a Total Knee Arthroplasty.

Condition or disease
Fat Embolism Syndrome

Detailed Description:

Computer assisted total knee arthroplasty is at its inception currently. There are many unknowns about this specific technique, particularly when it comes down to fat embolism syndrome. There is a high incidence of fat embolism during total knee arthroplasty as seen both by echocariography as well as sampling of right atrial blood. During a jig-based, or traditional, total knee arthroplasty, a rod is placed inside the femur, and sometimes the tibia as well. Intrusumentations of the medullary canal is known to cause fat embolism. Fat embolism is a syndrome which can produce post-operative confusion, hypoxemia, all the way to post-op and intra-operative death.

Computer assisted total knee arthroplasty does not use intramedullary jigs. It is presumed that by not instrumenting the medullary canal, the rate of fat embolism will be significantly reduced.

Fifty patient s will be studied while they are having a computer assisted total knee arthoplasty. A PICC line will be placed in their arm by an interventional radiologist pre-operatively. This PICC line will be thread into the right atrium. Right atrial blood will be sent to pathology every 10 minutes during the 60 to 90 minute procedure and at intervals post-op. The right atrial blood will be stained for bone marrow elements.

This study is to presumed to show yet another benefit of computer assisted surgery.


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Official Title: Incidence of Fat Embolism With Computer Assisted Total Knee Arthroplasty
Study Start Date : January 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who are deemed candidates for Computer Assisted Total Knee Arthroplasty
Criteria

Inclusion Criteria:

  • Must be a candidate for Computer Assisted Total Knee Arthroplasty

Exclusion Criteria:

  • Mentally incompetent patients excluded

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): NCT00656877


Locations
United States, West Virginia
Marshall University School Of Medicine, Department of Orthopaedics
Huntington, West Virginia, United States, 25701
Sponsors and Collaborators
Marshall University
Investigators
Principal Investigator: Ali Oliashirazi, MD Marshall University

Responsible Party: Ali Oliashirazi, MD, Marshall University School of Medicine
ClinicalTrials.gov Identifier: NCT00656877     History of Changes
Other Study ID Numbers: 6077
First Posted: April 11, 2008    Key Record Dates
Last Update Posted: April 11, 2008
Last Verified: April 2008

Keywords provided by Marshall University:
Fat Embolism Total Knee Arthroplasty

Additional relevant MeSH terms:
Embolism
Embolism, Fat
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases