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

Primary Purpose

Postoperative Complications, Memory Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pulsatile saline lavage
carbon dioxide lavage
Sponsored by
Kinamed Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications focused on measuring postoperative cognitive dysfunction, total knee arthroplasty, cerebral emboli, carbon dioxide lavage, pulsatile saline lavage

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Patients With Emboli in the High Category
Number of Patients With Delirium During Hospital Stay

Full Information

First Posted
August 14, 2008
Last Updated
September 3, 2019
Sponsor
Kinamed Incorporated
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00736125
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kinamed Incorporated
Collaborators
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Memory Disorders
Keywords
postoperative cognitive dysfunction, total knee arthroplasty, cerebral emboli, carbon dioxide lavage, pulsatile saline lavage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
pulsatile saline lavage
Intervention Description
Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
Intervention Type
Device
Intervention Name(s)
carbon dioxide lavage
Intervention Description
Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
Primary Outcome Measure Information:
Title
The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Number of Patients With Emboli in the High Category
Time Frame
During surgery
Title
Number of Patients With Delirium During Hospital Stay
Time Frame
First 3 days after surgery
Other Pre-specified Outcome Measures:
Title
Changes in Neurocognitive Tests Following Surgery
Description
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.
Time Frame
3 months following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terri G Monk, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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

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