A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events
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|ClinicalTrials.gov Identifier: NCT00736125|
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : April 18, 2013
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Complications Memory Disorders||Device: pulsatile saline lavage Device: carbon dioxide lavage||Not Applicable|
Elderly patients undergoing major, orthopedic surgery are at risk of developing postoperative cognitive dysfunction (POCD) or memory impairment following surgery. Transcranial doppler (TCD) monitoring of blood flow to the brain has detected cerebral emboli in 60% of patients following release of the thigh tourniquet during total knee replacement or arthroplasty (TKA). These cerebral embolic events may represent one of the mechanisms responsible for postoperative cognitive problems.
The standard surgical technique for TKA involves cleaning the bone surfaces with pulsed saline lavage prior to cementation and prosthesis insertion. The CarboJet Assisted technique utilizes carbon dioxide lavage to clean and dry the femur canal and bone surfaces prior to cementation and implantation. Because it removes fat globules and marrow particulates from the bone surfaces, it is hypothesized that the use of a carbon dioxide lavage technique in TKA will result in fewer thromboembolic events and increased cement penetration compared with the standard technique using pulsed saline lavage. Cement penetration affects the strength of the bone-cement interface and, therefore, contributes to implant longevity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Comparison of Intraoperative Embolic Events During Total Knee Arthroplasty Performed With CarboJet Assisted Versus Standard Orthopedic Techniques: A Pilot Study|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||March 2011|
|Active Comparator: 1||
Device: pulsatile saline lavage
Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
|Active Comparator: 2||
Device: carbon dioxide lavage
Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
- The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD) [ Time Frame: During surgery ]
- Number of Patients With Emboli in the High Category [ Time Frame: During surgery ]
- Number of Patients With Delirium During Hospital Stay [ Time Frame: First 3 days after surgery ]
- Changes in Neurocognitive Tests Following Surgery [ Time Frame: 3 months following surgery ]
Hopkins Verbal Learning Test (HVLT).This is a test of verbal learning and memory.
The scale is the number of words retained. The total score for the test administered ranges from 0 to 12. Higher values represent better outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736125
|United States, North Carolina|
|Veterans Affairs Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Terri G Monk, MD||Duke University|