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| Name | Class |
|---|---|
| Becton, Dickinson and Company | INDUSTRY |
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To examine in Arista hemostatic powder results in less post-total knee arthroplasty blood loss, hematoma formation, and improved range of motion when compared to patients who did not receive the product.
Patients will be recruited from the Hospital for Special Surgery and Our Lady of Lourdes Programs. Patients will be prospectively enrolled when Institutional Review Board (IRB) approval is obtained. All patients will be undergoing a primary unilateral total knee arthroplasty for a diagnosis of osteoarthritis. Once enrolled in the study, each patient will be randomized into one of two groups. Group A will undergo a TKA utilizing Arista MPH ® intra-operatively. Group B will undergo a TKA without Arista MPH ®. All patients will receive a baseline IV dose of tranexamic acid per weight based guidelines prior to incision.
A thigh tourniquet will be utilized from prior to incision until wound closure is complete. Arista MPH ® will be used intra-operatively. A 5 gram vial of Arista MPH will be the standard of use. ARISTA will be used in accordance with the instructions for use. Additional need for Arista MPH ® usage during the case will be permitted and recorded. Standard electrocautory will be permitted, however additional thermal devices intended for hemostatic control will not be utilized.
Pre-operative hemoglobin, hematocrit, PT, PTT, and INR will be per standard institutional protocol within 30 days of surgery. The hemoglobin and hematocrit will be repeated 24 hours after the procedure per standard physician protocol. IV fluids administered pre-op, intra-op and post op for the first 24 hours will be recorded. Administration of any blood products from the time of incision until 90 days post-op will be recorded. Blood loss will be calculated via standard HSS. Drains will not be utilized.
The transfusion criteria is: a hemoglobin level of <8 g/dL or a hemoglobin level of <10 g/dL in a patient with symptomatic anemia or deemed at high risk because of notable underlying cardiac comorbidities. Blood will be administered 1 unit at a time, and the presence of symptoms or signs was reassessed.
Pre-operative thigh circumference will be measured on the day of the surgery. For standardization, the circumference will be recorded 15 cm proximal to the superior pole of the patella. Post-operatively the thigh circumference will be measured at 24 hours, post-operative day 14 +/- 4 days, and post operatively at 3 months +/- 1 week.
Post-operative knee range of motion will be recorded at 24 hours, post-operative day 14 +/- 4 days, and post-operatively at 3 months +/- 1 week.
Pre-operative and post-operative day 14 (+/- 4 days) and post-operative 3 months (+/- 1 week) knee society short form scores will be collected All post-operative adverse events related to the procedure will be recorded. These invents include, but are not limited to: readmission, infection, prosthesis loosening, wound dehiscence, and wound drainage.
All data will be de-identified and securely maintained in an IRB approved manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arista group | Experimental | this group of randomized patients will receive 5 grams of arista hemostatic powder intra-operatively in their wound in addition to 1 gram of IV transexemic acid prior to incision |
|
| control group | No Intervention | this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arista | Drug | hemostatic powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss | Calculated on standard hospital protocol | Time of incision until 90 days post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Thigh Circumference | Thigh circumference measurement 15 cm above the top of the patella | 3 months post op |
| Range of Motion | Measured in degrees |
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Inclusion Criteria:
• They willingly desire to participate and signed the informed consent
Exclusion Criteria:
• allergy to Arista MPH®
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virtua Health System | Marlton | New Jersey | 08053-9697 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arista Group | this group of randomized patients will receive 5 grams of arista hemostatic powder intra-operatively in their wound in addition to 1 gram of IV transexemic acid prior to incision Arista: hemostatic powder |
| FG001 | Control Group | this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arista Group | this group of randomized patients will receive 5 grams of arista hemostatic powder intra-operatively in their wound in addition to 1 gram of IV transexemic acid prior to incision Arista: hemostatic powder |
| BG001 | Control Group |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Loss | Calculated on standard hospital protocol | Posted | Mean | Standard Deviation | cubic centimeters | Time of incision until 90 days post-op |
|
Enrollment to 90 Days post-op
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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 | Arista Group | this group of randomized patients will receive 5 grams of arista hemostatic powder intra-operatively in their wound in addition to 1 gram of IV transexemic acid prior to incision Arista: hemostatic powder |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission due to pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Readmission due to pain, unrelated to study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Non-systematic Assessment | Infection post procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean McMillan | Virtua Medical Group, PA | 908-812-7542 | smcmillan@virtua.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 13, 2020 | Apr 22, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 13, 2020 | Sep 25, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| C527600 | Arista |
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randomized controlled study
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patients are blinded as to their randomization group
| 3 months post op |
this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Thigh Circumference | Thigh circumference measurement 15 cm above the top of the patella | 61 patients were consented however some did not continue to the 3 month post op timepoint and therefore their data was not collected or analyzed. | Posted | Mean | Standard Deviation | centimeters | 3 months post op |
|
|
|
| Secondary | Range of Motion | Measured in degrees | 61 patients were consented however some did not continue to the 3 month post op timepoint and therefore their data was not collected or analyzed. | Posted | Mean | Standard Deviation | Degrees | 3 months post op |
|
|
|
| 0 |
| 31 |
| 3 |
| 31 |
| 2 |
| 31 |
| EG001 | Control Group | this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision | 0 | 28 | 2 | 28 | 0 | 28 |
|
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