An observational study in Total Knee Replacement and Venous Thromboembolism, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-08-15.
Sponsored by University of California, Davis · Observational
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.
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.
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's enrollment of 15 is below the median of 500 across 344 observational studies indexed under Thromboembolism.
Browse Thromboembolism studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients scheduled for elective total knee replacement
Exclusion Criteria:
Standard Total Knee Replacement
Procedure: Measurement of total thrombolic load
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
Total venous embolic load
Time frame: Acute, 5 minutes
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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University of California, Davis