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| Name | Class |
|---|---|
| University of Massachusetts, Amherst | OTHER |
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The primary purpose of this study is to conduct a multi-site clinical trial of the Recovery Force Movement and Compressions (RF MAC) System. The study is a randomized comparative study of DVT prophylaxis using either standard IPC (Group 1) or the RF MAC system (Group 2) in 300 patients after TJR surgery at two study sites: Tufts Medical Center (Boston, Massachusetts) and Eskenazi Hospital (Indianapolis, Indiana). This study is funded by a Phase II SBIR awarded to Recovery Force from the National Institutes of Health, National Heart, Lung and Blood Institute (R44-HL132624-02).
DVT is the most feared complication of total joint replacement (TJR), with more than 300,000 total hip and 700,000 total knee replacements performed annually in the U.S. Current recommendations for postoperative DVT prophylaxis after TJR include anti-coagulant medications and/or intermittent pneumatic compression (IPC) of the lower limb for a minimum of 10-14 days. Most current IPC devices are non-mobile, making early postoperative mobility, which is especially important in TJR patients, cumbersome and time-consuming. Upon hospital discharge, most patients go home on pharmacologic DVT prophylaxis. Even when at-home external compression therapy is prescribed (IPC or compression stockings), data suggests compliance rates as low as 10-50%.
Recovery Force (RF) has produced the next generation of mechanical DVT prophylaxis, with a mobile device absent of tubes and pumps, stays in place during ambulation, is lightweight and comfortable for continuous wear, and is designed to improve compliance with recommended use. The hypothesis for Phase II is that IPC using the RF1400 will result in improved compliance, support early mobility and result in significantly higher functional mobility after TJR as compared to standard of care.
The research team will conduct a randomized comparative study of DVT prophylaxis using either standard IPC (Group 1) or the RF1400 (Group 2) in 300 patients after TJR surgery. Dr. Karen Giuliano of the University of Massachusetts Amherst will serve as the overall PI for efforts associated with the study sites. This study will include an inpatient phase and an outpatient phase with patients at two clinical sites: Tufts Medical Center and Indiana University School of Medicine, with each site enrolling 150 patients (75 control/75 experimental).
The overall goal of Phase II is to demonstrate that compliance with perscribed use, comfort, and ease-of-use is significantly higher with the RF1400 than with DVT prophylaxis using either standard IPC (in-hospital) or standard-of-care (at-home) in preparation for full commercialization in the TJR market during Phase III. The DVT therapy market is expected to hit $3.8B by 2021, and the US accounts for over 50% of the global market. With the current risk of bleeding from anticoagulant DVT prophylaxis at 5.6%, the commercial impact of this research is that improved patient compliance with the RF1400 DVT prophylaxis will improve postoperative mobility and provide an effective alternative to anticoagulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Participants will receive DVT prophylaxis using standard intermittent pneumatic compression during postoperative care after total joint replacement. | |
| Recovery Force MAC | Experimental | Participants will receive DVT prophylaxis using the RF Health MAC during postoperative care after total joint replacement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF Health MAC | Device | The RF Health MAC is a novel device that is applied to the lower legs of patients that provides intermittent active compressions to the calf muscles which results in increased blood flow in the veins, moving blood towards the direction of the heart and reducing the risk of clot formation. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance to Prescribed Use | Compare patient compliance (percentage of prescribed use/24hr) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients. | day 1 postoperative joint replacement |
| Patient-reported Comfort | Compare patient-reported comfort (patient reported outcomes in the hospital-standard of care vs RF MAC-for overall comfort, where higher score is better device performance (5-pt Likert Scale; 1=Strongly disagree, 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly Agree) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients. | at the end of 14-day data collection period |
| Patient-reported Ease-of-use | Compare patient-reported ease-of-use (using the System Usability Scale, with a range of 0-21, where higher score =higher ease of use) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients. | at the end of 14-day data collection period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts | Boston | Massachusetts | 02111 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Participants received DVT prophylaxis using standard intermittent pneumatic compression during postoperative care after total joint replacement. |
| FG001 | Recovery Force MAC | Participants received DVT prophylaxis using the RF Health MAC during postoperative care after total joint replacement. RF Health MAC: The RF Health MAC is a novel device that is applied to the lower legs of patients that provides intermittent active compressions to the calf muscles which results in increased blood flow in the veins, moving blood towards the direction of the heart and reducing the risk of clot formation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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We used the same analysis population that was described in our research.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Participants received DVT prophylaxis using standard intermittent pneumatic compression during postoperative care after total joint replacement. |
| BG001 | Recovery Force MAC |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Compliance to Prescribed Use | Compare patient compliance (percentage of prescribed use/24hr) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients. | Percent Compliance for Day 1 postop | Posted | Mean | Standard Deviation | percentage of prescribed use/24hr | day 1 postoperative joint replacement |
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Adverse events reports were collected through study completion (14 days).
Used standard definitions
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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 | Standard of Care | Participants received DVT prophylaxis using standard intermittent pneumatic compression during postoperative care after total joint replacement. |
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Due to COVID and one of the sites losing their most high volume orthopedic surgeon, this trial was significantly under-enrolled and underpowered
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Schwegman (PI), Dr. Karen Giuliano (PI, clinical trial subaward) | Recovery Force Health, University of Massachusetts Amherst | 317-605-4696; 224-725-0270 | kschwegman@recoveryforceusa.com; kkgiuliano@umass.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2021 | Jun 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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This study will have 2 groups, intervention (RF MAC-group 2) and control (usual care for DVT prevention and mobility-group 1) in postoperative total joint replacement patients at two hospitals.
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Participants received DVT prophylaxis using the RF Health MAC during postoperative care after total joint replacement.
RF Health MAC: The RF Health MAC is a novel device that is applied to the lower legs of patients that provides intermittent active compressions to the calf muscles which results in increased blood flow in the veins, moving blood towards the direction of the heart and reducing the risk of clot formation.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Patient-reported Comfort | Compare patient-reported comfort (patient reported outcomes in the hospital-standard of care vs RF MAC-for overall comfort, where higher score is better device performance (5-pt Likert Scale; 1=Strongly disagree, 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly Agree) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients. | Patient reported outcomes in the hospital (Standard of care vs RF MAC) for overall comfort, where higher score is better device performance (5-pt Likert Scale; 1=Strongly disagree, 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly Agree). | Posted | Mean | Standard Deviation | units on a scale | at the end of 14-day data collection period |
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| Primary | Patient-reported Ease-of-use | Compare patient-reported ease-of-use (using the System Usability Scale, with a range of 0-21, where higher score =higher ease of use) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients. | Patient reported ease-of-use (using the System Usability Scale, with a range of 0-21, where higher score =higher ease of use) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients. | Posted | Mean | Standard Deviation | units on a scale | at the end of 14-day data collection period |
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| 49 |
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| 49 |
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| 49 |
| EG001 | Recovery Force MAC | Participants received DVT prophylaxis using the RF Health MAC during postoperative care after total joint replacement. RF Health MAC: The RF Health MAC is a novel device that is applied to the lower legs of patients that provides intermittent active compressions to the calf muscles which results in increased blood flow in the veins, moving blood towards the direction of the heart and reducing the risk of clot formation. | 0 | 57 | 0 | 57 | 0 | 57 |
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