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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755300
• Other study ID #: 200614481
• Status: Completed
• Phase: N/A
• First received: September 17, 2008
• Last updated: August 11, 2011
• Start date: June 2006
• Est. completion date: June 2009

Study information

• Verified date: August 2011
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thromboembolism
• Total Knee Replacement
• Venous Thromboembolism

Intervention

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

Locations

Country	Name	City	State
United States	University of California, Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total venous embolic load		Acute, 5 minutes	Yes