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The use of Aquamantys during total knee arthroplasty will reduce drain output and the necessity for blood transfusions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKA with the Aquamantys for hemostasis | Experimental | This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis. |
|
| TKA without the Aquamantys for hemostasis | Active Comparator | This group will receive total knee arthroplasty using the standard treatment for hemostasis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquamantys Device | Device | The Aquamantys is used for hemostasis in patients randomized to receive total knee arthroplasty with the device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drain Output. | This is a measure of the average drain output collected in the first 24 hours following surgery. | First 24 hours following surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun Jin Kim, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jack D. Weiler Hospital-Division of Montefiore Medical Center | The Bronx | New York | 10461 | United States | ||
Patients who were on anticoagulation therapy prior to their TKA were excluded from our study as this potentially would increase their amount of post-operative bleeding complicating the results of our study.
Patients were recruited from the medical clinics of Weiler and Montefiore hospitals under the Montefiore system in the Bronx, NY. Patients undergoing a total knee arthroplasty (TKA) were recruited over a 10 month period and either received hemostasis with the standard unipolar cauterizing device or the bipolar saline system.
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| ID | Title | Description |
|---|---|---|
| FG000 | TKA With the Aquamantys for Hemostasis | This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis. |
| FG001 | TKA Without the Aquamantys for Hemostasis | This group will receive total knee arthroplasty using the standard treatment for hemostasis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TKA With the Aquamantys for Hemostasis | This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis. |
| BG001 | TKA Without the Aquamantys for Hemostasis |
| 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 | Drain Output. | This is a measure of the average drain output collected in the first 24 hours following surgery. | Posted | Oct 2010 | Mean | Standard Deviation | mL | First 24 hours following 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 | TKA With the Aquamantys for Hemostasis | This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis. |
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Operator dependent modifications may affect the standardization of the procedure; Surgeon is not blinded to the treatment used on each patient.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sun Jin Kim | Montefiore Medical Center | 718-920-2060 | sukim@montefiore.org |
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| Standard of care treatment for hemostasis during a total knee arthroplasty. | Other | The active comparator arm will receive the "standard-of-care" for hemostasis during total knee arthroplasty. This is achieved with a unipolar Bovie electrocauterization device. |
|
| Montefiore Medical Center |
| The Bronx |
| New York |
| 10467 |
| United States |
This group will receive total knee arthroplasty using the standard treatment for hemostasis.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
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| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | TKA Without the Aquamantys for Hemostasis | This group will receive total knee arthroplasty using the standard treatment for hemostasis. | 0 | 61 | 0 | 61 |
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