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

NCT ID: NCT00736125

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2011-03-31

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.

Conditions

Postoperative Complications; Memory Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

pulsatile saline lavage

Intervention Type: DEVICE

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

2

Group Type: ACTIVE_COMPARATOR

carbon dioxide lavage

Intervention Type: DEVICE

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

Interventions

pulsatile saline lavage

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

Intervention Type: DEVICE

carbon dioxide lavage

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Kinamed Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terri G Monk, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Veterans Affairs Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

01226

Identifier Type: -

Identifier Source: org_study_id