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

Not Applicable

Completed

• Conditions: Memory Disorders; Postoperative Complications
• Interventions: Device: pulsatile saline lavage; Device: carbon dioxide lavage

• Registration Number: NCT00736125
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Primary Completion: 2009-09
• Study Completion: 2011-03
• Results First Submitted: 2013-03-05
• Results First Submitted QC: 2013-04-16
• Results First Posted: 2013-04-18
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	pulsatile saline lavage	-
2	carbon dioxide lavage	-

Primary Outcome Measures

Name	Time	Method
The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)	During surgery

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Emboli in the High Category	During surgery
Number of Patients With Delirium During Hospital Stay	First 3 days after surgery

Trial Locations

Locations (1)

Veterans Affairs Medical Center; 🇺🇸 Durham, North Carolina, United States