A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events
A Comparison of Intraoperative Embolic Events During Total Knee Arthroplasty Performed With CarboJet Assisted Versus Standard Orthopedic Techniques: A Pilot Study
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 14, 2008
CompletedFirst Posted
Study publicly available on registry
August 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
April 18, 2013
CompletedSeptember 26, 2019
September 1, 2019
1.8 years
August 14, 2008
March 5, 2013
September 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)
During surgery
Secondary Outcomes (2)
Number of Patients With Emboli in the High Category
During surgery
Number of Patients With Delirium During Hospital Stay
First 3 days after surgery
Other Outcomes (1)
Changes in Neurocognitive Tests Following Surgery
3 months following surgery
Study Arms (2)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATORInterventions
Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
Eligibility Criteria
You may qualify if:
- Adult patients aged 50 years or older who are scheduled for elective TKA with a cemented Smith and Nephew Prosthesis design
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kinamed Incorporatedlead
- US Department of Veterans Affairscollaborator
Study Sites (1)
Veterans Affairs Medical Center
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Terri Monk
- Organization
- Duke University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Terri G Monk, MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2008
First Posted
August 15, 2008
Study Start
December 1, 2007
Primary Completion
September 1, 2009
Study Completion
March 1, 2011
Last Updated
September 26, 2019
Results First Posted
April 18, 2013
Record last verified: 2019-09