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| Name | Class |
|---|---|
| Salient Surgical Technologies | INDUSTRY |
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The present prospective, single-center, clinical trial is designed to evaluate the hemostatic efficacy of the hemostatic sealer Aquamantys 6.0™ in patients managed with total hip arthroplasty (THA). It is hypothesized that Aquamantys 6.0™ can improve hemostasis following total hip arthroplasty. Comparison of the functional and clinical results between THA patients having been exposed to Aquamantys 6.0™ versus a control group will be analyzed using several outcome measures including the Harris Hip Score and a pain scale. The primary variable of interest is transfusion requirements - specifically, number of patients managed with blood transfusion during the hospital stay after surgery. However, of secondary interest will be: 1) number of units transfused, 2) estimated intraoperative total blood loss, 3) change in pre- and post-operative hemoglobin levels, 4) total narcotic usage during hospital stay, 5) length of stay, 6) functional and pain outcomes (Harris Hip Score and Pain Scale), and 7) adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Bovie Electrocautery | Placebo Comparator | Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels. |
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| Bipolar Radiofrequency | Experimental | Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bipolar Radiofrequency (Aquamantys 6.0) | Device |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Managed With Blood Transfusion | daily during hospital stay (an expected average of 4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Units Transfused | daily during hospital stay (an expected average of 4 days) | |
| Estimated Blood Loss | Intraoperative (day of surgery) | |
| Change in Hemoglobin Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wael K Barsoum, MD | The Cleveland Clinic | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21411700 | Result | Barsoum WK, Klika AK, Murray TG, Higuera C, Lee HH, Krebs VE. Prospective randomized evaluation of the need for blood transfusion during primary total hip arthroplasty with use of a bipolar sealer. J Bone Joint Surg Am. 2011 Mar 16;93(6):513-8. doi: 10.2106/JBJS.J.00036. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bipolar Radiofrequency | Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery. |
| FG001 | Standard Bovie Electrocautery | Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bipolar Radiofrequency | Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Units Transfused | Posted | Mean | Standard Deviation | units of blood | daily during hospital stay (an expected average of 4 days) |
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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 | Bipolar Radiofrequency | Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wael K Barsoum, MD | The Cleveland Clinic | 216-444-7515 | barsouw@ccf.org |
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| Standard Bovie Electrocautery |
| Device |
|
Change in hemoglobin level from baseline to the day of hospital discharge. |
| within 30 days before surgery (preop), day of hospital discharge |
| Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay | Sum of daily morphine-equivalent mg narcotic usage during hospital stay. | daily during hospital stay (an expected average of 4 days) |
| Length of Stay | day of hospital discharge |
| Harris Hip Score (Outcome Score) | A scoring system used to evaluate the outcome after total hip replacement. Domains include pain (44 points), function (47 points), deformity (4 points), and range of motion (5 points). A total score is computed by summing the individual domain scores, with a maximum of 100 points. Higher values represent better outcomes. A total Harris Hip Score below 70 points is generally considered a poor result, 70 to 80 fair, 80 to 90 good, and 90 to 100 excellent. | within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery |
| Pain Score Scale | A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing "no pain" and 10 representing "unbearable pain." Thus, in this context, lower values represent better outcomes. | within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery |
| BG001 | Standard Bovie Electrocautery | Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Body-Mass Index | Mean | Standard Deviation | kg/m2 |
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| Baseline Hemoglobin | Mean | Standard Deviation | g/dL |
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| Primary | Number of Patients Managed With Blood Transfusion | Posted | Number | participants | daily during hospital stay (an expected average of 4 days) |
|
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| Secondary | Estimated Blood Loss | Posted | Mean | Standard Deviation | mL | Intraoperative (day of surgery) |
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| Secondary | Change in Hemoglobin Level | Change in hemoglobin level from baseline to the day of hospital discharge. | Posted | Mean | Standard Deviation | g/dL | within 30 days before surgery (preop), day of hospital discharge |
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| Secondary | Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay | Sum of daily morphine-equivalent mg narcotic usage during hospital stay. | Posted | Mean | Standard Deviation | total morphine-equivalent mg | daily during hospital stay (an expected average of 4 days) |
|
|
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| Secondary | Length of Stay | Posted | Mean | Standard Deviation | days | day of hospital discharge |
|
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| Secondary | Harris Hip Score (Outcome Score) | A scoring system used to evaluate the outcome after total hip replacement. Domains include pain (44 points), function (47 points), deformity (4 points), and range of motion (5 points). A total score is computed by summing the individual domain scores, with a maximum of 100 points. Higher values represent better outcomes. A total Harris Hip Score below 70 points is generally considered a poor result, 70 to 80 fair, 80 to 90 good, and 90 to 100 excellent. | Posted | Mean | Standard Deviation | points on a scale | within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery |
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| Secondary | Pain Score Scale | A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing "no pain" and 10 representing "unbearable pain." Thus, in this context, lower values represent better outcomes. | Posted | Mean | Standard Deviation | points on a scale | within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery |
|
|
|
| 0 |
| 71 |
| 2 |
| 71 |
| EG001 | Standard Bovie Electrocautery | Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels. | 0 | 69 | 4 | 69 |
| Coronary Ischemic Event | Cardiac disorders | Systematic Assessment |
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| Deep-Vein Thrombosis | Vascular disorders | Systematic Assessment |
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| Pulmonary Embolism | Vascular disorders | Systematic Assessment |
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| 12 Weeks Postoperative |
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| 12 Weeks Postoperative |
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