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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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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.
Elderly patients undergoing major, orthopedic surgery are at risk of developing postoperative cognitive dysfunction (POCD) or memory impairment following surgery. Transcranial doppler (TCD) monitoring of blood flow to the brain has detected cerebral emboli in 60% of patients following release of the thigh tourniquet during total knee replacement or arthroplasty (TKA). These cerebral embolic events may represent one of the mechanisms responsible for postoperative cognitive problems.
The standard surgical technique for TKA involves cleaning the bone surfaces with pulsed saline lavage prior to cementation and prosthesis insertion. The CarboJet Assisted technique utilizes carbon dioxide lavage to clean and dry the femur canal and bone surfaces prior to cementation and implantation. Because it removes fat globules and marrow particulates from the bone surfaces, it is hypothesized that the use of a carbon dioxide lavage technique in TKA will result in fewer thromboembolic events and increased cement penetration compared with the standard technique using pulsed saline lavage. Cement penetration affects the strength of the bone-cement interface and, therefore, contributes to implant longevity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulsatile saline lavage | Device | Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD) | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Emboli in the High Category | During surgery | |
| Number of Patients With Delirium During Hospital Stay | First 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Neurocognitive Tests Following Surgery | 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. | 3 months following surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terri G Monk, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center | Durham | North Carolina | 27705 | United States |
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during pre-op workup for TKA, patients were informed about study and asked if they wanted to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Pulsatile Saline Lavage | pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage |
| FG001 | 2 Carbon Dioxide Lavage | carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Pulsatile Saline Lavage | pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage |
| BG001 | 2 Carbon Dioxide Lavage | carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD) | Posted | Number | emboli | During surgery |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Pulsatile Saline Lavage | pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Terri Monk | Duke University Medical Center | 919-286-6938 | terri.monk@duke.edu |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D008569 | Memory Disorders |
| D000079690 | Postoperative Cognitive Complications |
| D020766 | Intracranial Embolism |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| carbon dioxide lavage | Device | Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Patients With Emboli in the High Category | Posted | Number | Patients w/ emboli in high category | During surgery |
|
|
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| Secondary | Number of Patients With Delirium During Hospital Stay | Posted | Count of Participants | Participants | First 3 days after surgery |
|
|
|
|
| Other Pre-specified | Changes in Neurocognitive Tests Following Surgery | 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. | Posted | Mean | Standard Error | score on a scale | 3 months following surgery |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 2 Carbon Dioxide Lavage | carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage | 0 | 10 | 0 | 10 |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002542 | Intracranial Embolism and Thrombosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |