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NCT00656877 Clinical Trial

Incidence of Fat Embolism With Computer Assisted Total Knee Arthroplasty

Fat Embolism Syndrome Clinical Trial

— Fat Embolism  

Official title:
Incidence of Fat Embolism With Computer Assisted Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00656877
Other study ID # 6077
Secondary ID
Status Completed
Phase N/A
First received December 27, 2007
Last updated April 4, 2008
Start date January 2006
Est. completion date March 2008

Study information
Verified date April 2008
Source Marshall University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Must be a candidate for Computer Assisted Total Knee Arthroplasty

Exclusion Criteria:

- Mentally incompetent patients excluded

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

Locations
Country Name City State
United States Marshall University School Of Medicine, Department of Orthopaedics Huntington West Virginia

Sponsors (1)
Lead Sponsor Collaborator
Marshall University

Country where clinical trial is conducted

United States,