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OpenTrials
Completed

NCT Number: NCT00736125

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pulsatile saline lavage

Device

Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage

carbon dioxide lavage

Device

Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage

Primary outcomes

  1. The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)

    Time frame: During surgery

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kinamed Incorporated

Industry

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Aug 15, 2008
Registry last updated
Sep 26, 2019

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.

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