A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events
This study has been completed.
Sponsor:
Kinamed Incorporated
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
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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
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
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
| 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
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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
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 |