Clinical trial NCT00736125: A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events
Official title: A Comparison of Intraoperative Embolic Events During Total Knee Arthroplasty Performed With CarboJet Assisted Versus Standard Orthopedic Techniques: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Memory Disorders
Keywords: postoperative cognitive dysfunction
total knee arthroplasty
cerebral emboli
carbon dioxide lavage
pulsatile saline lavage
Lead sponsor: Kinamed Incorporated
Sponsor class: INDUSTRY
Collaborators: name: US Department of Veterans Affairs
First posted: 2008-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)
timeFrame: During surgery
Secondary outcomes:
measure: Number of Patients With Emboli in the High Category
timeFrame: During surgery
measure: Number of Patients With Delirium During Hospital Stay
timeFrame: First 3 days after surgery
Other outcomes:
measure: Changes in Neurocognitive Tests Following Surgery
timeFrame: 3 months following surgery
Locations:
city: Durham
country: United States
facility: Veterans Affairs Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Terri G Monk, MD
role: PRINCIPAL_INVESTIGATOR
References: