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

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.

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Key information

Conditions

Total Knee Replacement Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of total thrombolic load

Procedure

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

Primary outcomes

Total venous embolic load

Time frame: Acute, 5 minutes

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2009
First posted: Sep 18, 2008
Registry last updated: Aug 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed