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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Memory Disorders
• Intervention / Treatment: Device: pulsatile saline lavage; Device: carbon dioxide lavage

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Veterans Affairs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Device: carbon dioxide lavage; Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
Active Comparator: 1	Device: pulsatile saline lavage; Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)	During surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Patients With Emboli in the High Category	During surgery
Number of Patients With Delirium During Hospital Stay	First 3 days after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Neurocognitive Tests 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.	3 months following surgery

Collaborators and Investigators

• Sponsor: Kinamed Incorporated
• Collaborators: US Department of Veterans Affairs
• Investigators: Principal Investigator: Terri G Monk, MD, Duke University

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: August 14, 2008
• First Submitted That Met QC Criteria: August 14, 2008
• First Posted (Estimate): August 15, 2008

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: total knee arthroplasty; postoperative cognitive dysfunction; cerebral emboli; carbon dioxide lavage; pulsatile saline lavage
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Postoperative Complications; Memory Disorders
• Other Study ID Numbers: 01226