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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kinamed Incorporated
ClinicalTrials.gov Identifier:
NCT00736125
First received: August 14, 2008
Last updated: April 17, 2013
Last verified: April 2013
Results First Received: March 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Postoperative Complications
Memory Disorders
Interventions: Device: pulsatile saline lavage
Device: carbon dioxide lavage

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
during pre-op workup for TKA, patients were informed about study and asked if they wanted to participate.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
1 Pulsatile Saline Lavage pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
2 Carbon Dioxide Lavage carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage

Participant Flow:   Overall Study
    1 Pulsatile Saline Lavage     2 Carbon Dioxide Lavage  
STARTED     10     10  
COMPLETED     9     8  
NOT COMPLETED     1     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 Pulsatile Saline Lavage pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
2 Carbon Dioxide Lavage carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
Total Total of all reporting groups

Baseline Measures
    1 Pulsatile Saline Lavage     2 Carbon Dioxide Lavage     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     6     12  
>=65 years     4     4     8  
Age  
[units: years]
Mean ± Standard Deviation
  62.3  ± 3.3     63.9  ± 3.7     63.1  ± 3.5  
Gender  
[units: participants]
     
Female     0     0     0  
Male     10     10     20  
Region of Enrollment  
[units: participants]
     
United States     10     10     20  



  Outcome Measures
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1.  Primary:   The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)   [ Time Frame: During surgery ]

2.  Secondary:   Number of Patients With Emboli in the High Category   [ Time Frame: During surgery ]

3.  Secondary:   Changes in Neurocognitive Tests Following Surgery   [ Time Frame: 2 weeks prior to 1 year following surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Delirium During Hospital Stay   [ Time Frame: First 3 days after surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Changes in Pulmonary and Renal Function   [ Time Frame: Within 3 days after surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Cardiac Injury   [ Time Frame: Within 3 days after surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Systemic Inflammatory Response (SIRS) Markers   [ Time Frame: Within 72 hours after surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Biomarkers of Neuronal Damage   [ Time Frame: Within 72 hours after surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Terri Monk
Organization: Duke University Medical Center
phone: 919-286-6938
e-mail: terri.monk@duke.edu


No publications provided


Responsible Party: Kinamed Incorporated
ClinicalTrials.gov Identifier: NCT00736125     History of Changes
Other Study ID Numbers: 01226
Study First Received: August 14, 2008
Results First Received: March 5, 2013
Last Updated: April 17, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration