A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events



Status:Completed
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:50 - Any
Updated:8/9/2018
Start Date:December 2007
End Date:March 2011

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A Comparison of Intraoperative Embolic Events During Total Knee Arthroplasty Performed With CarboJet Assisted Versus Standard Orthopedic Techniques: A Pilot Study

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.

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.

Inclusion Criteria:

- Adult patients aged 50 years or older who are scheduled for elective TKA with a
cemented Smith and Nephew Prosthesis design

Exclusion Criteria:

- Dementia or severe cognitive impairment

- Severe visual or hearing impairments

- Inability to follow directions or comprehend the English language

- Females who are pregnant

- Abnormal distal femur geometry

- Pre-existing hardware or abnormal bony architecture in the proximal tibia
We found this trial at
1
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Durham, North Carolina 27705
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Durham, NC
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