Total Knee Arthroplasty And Thromboembolism: A Comparison Between Two Surgical Techniques

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00755300
First received: September 17, 2008
Last updated: August 11, 2011
Last verified: August 2011
  Purpose

In patients undergoing total knee arthroplasty, thromboembolism is a common occurrence, especially following tourniquet deflation. The resulting cardiopulmonary emboli can potentially lead to hypoxemia, hypotension, hemodynamic collapse and post operative cognitive dysfunction due to emboli. The standard surgical technique involves placing an intramedullary rod in the femur to determine the angle and degree of resection from the end of the femur. A new surgical technique utilizes computer navigation system to perform the desired cuts in the appropriate position. The investigators hypothesize that the avoidance of intramedullary instrumentation in computer assisted total knee replacement will result in fewer thromboembolic events compared with the standard technique using manual instrumentation in the femur. The present study will test this hypothesis by quantifying the extent of thromboembolism during both surgical techniques.


Condition Intervention
Total Knee Replacement
Venous Thromboembolism
Procedure: Measurement of total thrombolic load

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Total Knee Arthroplasty And Thromboembolism: A Comparison Between Two Surgical Techniques

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Total venous embolic load [ Time Frame: Acute, 5 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: June 2006
Study Completion Date: June 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Standard Total Knee Replacement
Procedure: Measurement of total thrombolic load
A video recording of the right atrium using TE echo will be used to quantitate the total thromboembolic load
2
Computer Guided Knee Replacement
Procedure: Measurement of total thrombolic load
A video recording of the right atrium using TE echo will be used to quantitate the total thromboembolic load

Detailed Description:

Currently, Transesophageal Echocardiography (TEE) is routinely used intraoperatively to monitor patients undergoing total knee arthroplasty for thromboembolic events. Video recording (without any patient identifiers) of the TEE loops before and after tourniquet release, offline analysis to quantify the extent of thromboembolism and the two surgical techniques will be compared. Patients are assigned to a particular technique according to some non-rigid criteria. This study has no impact on their selection into one group or the other. Participation in this study does not influence the choice/selection. We will simply record and analyze the echo loops in twenty patients already assigned to each surgical technique.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients scheduled for elective total knee replacement

Criteria

Inclusion Criteria:

  • Adult patients scheduled to undergo Total Knee Arthroplasty at UC Davis Medical Center
  • 18 years and above

Exclusion Criteria:

  • Any contraindication to perform TEE
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755300

Locations
United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Amrik Singh, M.D. Associate Professor, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
  More Information

No publications provided

Responsible Party: Amrik Singh, M.D., University of California Davis Department of Anesthesiology & Pain Medicine
ClinicalTrials.gov Identifier: NCT00755300     History of Changes
Other Study ID Numbers: 200614481
Study First Received: September 17, 2008
Last Updated: August 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Total knee replacement
esophageal echocardiography

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on April 17, 2014