Veterans Affairs Medical Center
Durham, North Carolina, 27705, United States
NCT Number: NCT00736125
The purpose of this study is to determine if the use of a carbon dioxide lavage device (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic events when compared with standard orthopedic techniques.
Looking for future studies?
Notify Me50 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27705, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
Time frame: During surgery
Time frame: During surgery
Time frame: First 3 days after 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.
Kinamed Incorporated
Industry
A Comparison of Intraoperative Embolic Events During Total Knee Arthroplasty Performed With CarboJet Assisted Versus Standard Orthopedic Techniques: A Pilot Study
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.
Published trials that share one or more normalized conditions with this study.
NCT00512200
Delirium, Dementia, Amnestic, Cognitive Disorders, Memory Disorders
Basel, Canton of Basel-City, Switzerland
View Trial DetailsNCT02662257
Cognition Disorders, Cognitive Dysfunction
Beijing, Beijing Municipality, China
View Trial DetailsNCT04191642
Cognition Disorders, Cognitive Dysfunction
Yinchuan, Ningxia, China
View Trial DetailsNCT02766062
Cognition Disorders, Cognitive Dysfunction
View Trial Details