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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736125
• Other study ID #: 01226
• Status: Completed
• Phase: N/A
• Start date: December 2007
• Est. completion date: March 2011

Study information

• Verified date: September 2019
• Source: Kinamed Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Memory Disorders
• Postoperative Complications

Intervention

Device:
• pulsatile saline lavage
Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
• carbon dioxide lavage
Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Kinamed Incorporated	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)		During surgery
Secondary	Number of Patients With Emboli in the High Category		During surgery
Secondary	Number of Patients With Delirium During Hospital Stay		First 3 days after surgery