Status:
COMPLETED
A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events
Lead Sponsor:
Kinamed Incorporated
Collaborating Sponsors:
US Department of Veterans Affairs
Conditions:
Postoperative Complications
Memory Disorders
Eligibility:
All Genders
50+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- Adult patients aged 50 years or older who are scheduled for elective TKA with a cemented Smith and Nephew Prosthesis design
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00736125
Start Date
December 1 2007
End Date
March 1 2011
Last Update
September 26 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Veterans Affairs Medical Center
Durham, North Carolina, United States, 27705