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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00736125
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : April 18, 2013
Last Update Posted : September 26, 2019
US Department of Veterans Affairs
Information provided by (Responsible Party):
Kinamed Incorporated

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.

Condition or disease Intervention/treatment Phase
Postoperative Complications Memory Disorders Device: pulsatile saline lavage Device: carbon dioxide lavage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD) [ Time Frame: During surgery ]

Secondary Outcome Measures :
  1. Number of Patients With Emboli in the High Category [ Time Frame: During surgery ]
  2. Number of Patients With Delirium During Hospital Stay [ Time Frame: First 3 days after surgery ]

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00736125

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United States, North Carolina
Veterans Affairs Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Kinamed Incorporated
US Department of Veterans Affairs
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Principal Investigator: Terri G Monk, MD Duke University

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Responsible Party: Kinamed Incorporated Identifier: NCT00736125     History of Changes
Other Study ID Numbers: 01226
First Posted: August 15, 2008    Key Record Dates
Results First Posted: April 18, 2013
Last Update Posted: September 26, 2019
Last Verified: September 2019
Keywords provided by Kinamed Incorporated:
postoperative cognitive dysfunction
total knee arthroplasty
cerebral emboli
carbon dioxide lavage
pulsatile saline lavage
Additional relevant MeSH terms:
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Memory Disorders
Postoperative Complications
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms