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

NCT ID: NCT00755300

Last Updated: 2011-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-06-30

Brief 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.

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.

Conditions

Total Knee Replacement; Venous Thromboembolism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Standard Total Knee Replacement

Measurement of total thrombolic load

Intervention Type: PROCEDURE

A video recording of the right atrium using TE echo will be used to quantitate the total thromboembolic load

2

Computer Guided Knee Replacement

Measurement of total thrombolic load

Intervention Type: PROCEDURE

A video recording of the right atrium using TE echo will be used to quantitate the total thromboembolic load

Interventions

Measurement of total thrombolic load

A video recording of the right atrium using TE echo will be used to quantitate the total thromboembolic load

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

University of California Davis Department of Anesthesiology & Pain Medicine

Principal Investigators

Amrik Singh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine

Locations

University of California, Davis Medical Center

Sacramento, California, United States

Countries

United States

Other Identifiers

200614481

Identifier Type: -

Identifier Source: org_study_id