Incidence of Fat Embolism With Computer Assisted Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by:
Marshall University
ClinicalTrials.gov Identifier:
NCT00656877
First received: December 27, 2007
Last updated: April 4, 2008
Last verified: April 2008
  Purpose

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


Condition
Fat Embolism Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Incidence of Fat Embolism With Computer Assisted Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Marshall University:

Estimated Enrollment: 50
Study Start Date: January 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Ali Oliashirazi, MD, Marshall University School of Medicine
ClinicalTrials.gov Identifier: NCT00656877     History of Changes
Other Study ID Numbers: 6077
Study First Received: December 27, 2007
Last Updated: April 4, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Marshall University:
Fat Embolism Total Knee Arthroplasty

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

ClinicalTrials.gov processed this record on August 18, 2014