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

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ClinicalTrials.gov Identifier: NCT00736125
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : April 18, 2013
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
Kinamed Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Postoperative Complications
Memory Disorders
Interventions Device: pulsatile saline lavage
Device: carbon dioxide lavage
Enrollment 20
Recruitment Details during pre-op workup for TKA, patients were informed about study and asked if they wanted to participate.
Pre-assignment Details  
Arm/Group Title 1 Pulsatile Saline Lavage 2 Carbon Dioxide Lavage
Hide Arm/Group Description 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
Period Title: Overall Study
Started 10 10
Completed 9 8
Not Completed 1 2
Arm/Group Title 1 Pulsatile Saline Lavage 2 Carbon Dioxide Lavage Total
Hide Arm/Group Description 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 Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  60.0%
6
  60.0%
12
  60.0%
>=65 years
4
  40.0%
4
  40.0%
8
  40.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
62.3  (3.3) 63.9  (3.7) 63.1  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
10
 100.0%
20
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)
Hide Description [Not Specified]
Time Frame During surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Pulsatile Saline Lavage 2 Carbon Dioxide Lavage
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 7 6
Measure Type: Number
Unit of Measure: emboli
0 3
2.Secondary Outcome
Title Number of Patients With Emboli in the High Category
Hide Description [Not Specified]
Time Frame During surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Pulsatile Saline Lavage 2 Carbon Dioxide Lavage
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 9 8
Measure Type: Number
Unit of Measure: Patients w/ emboli in high category
9 5
3.Secondary Outcome
Title Number of Patients With Delirium During Hospital Stay
Hide Description [Not Specified]
Time Frame First 3 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Pulsatile Saline Lavage 2 Carbon Dioxide Lavage
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
1
  10.0%
4
  40.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 Pulsatile Saline Lavage, 2 Carbon Dioxide Lavage
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments nonparametric data were analyzed using Mann Whitney U Tests
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Changes in Neurocognitive Tests Following Surgery
Hide Description

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.

Time Frame 3 months following surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Pulsatile Saline Lavage 2 Carbon Dioxide Lavage
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 9 10
Mean (Standard Error)
Unit of Measure: score on a scale
1.67  (1.6) 4.7  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 Pulsatile Saline Lavage, 2 Carbon Dioxide Lavage
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 Pulsatile Saline Lavage 2 Carbon Dioxide Lavage
Hide Arm/Group Description 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
All-Cause Mortality
1 Pulsatile Saline Lavage 2 Carbon Dioxide Lavage
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1 Pulsatile Saline Lavage 2 Carbon Dioxide Lavage
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 Pulsatile Saline Lavage 2 Carbon Dioxide Lavage
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Terri Monk
Organization: Duke University Medical Center
Phone: 919-286-6938
EMail: terri.monk@duke.edu
Layout table for additonal information
Responsible Party: Kinamed Incorporated
ClinicalTrials.gov Identifier: NCT00736125     History of Changes
Other Study ID Numbers: 01226
First Submitted: August 14, 2008
First Posted: August 15, 2008
Results First Submitted: March 5, 2013
Results First Posted: April 18, 2013
Last Update Posted: September 26, 2019