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This study will prospectively compare compliance rates between a novel FDA cleared wearable compression therapy with and without digital engagement for DVT prophylaxis in both hospital and home environments after total knee or hip arthroplasty.
This study is a single-arm, open-label, prospective, single-center study designed to evaluate compliance to CirvoTM therapy use with and without digital engagement. Historical questionnaire data with a different compression device will be compared to the same questionnaire used for the prospective cohort of up to 200 subjects. All patients prescribed compression therapy following total joint arthroscopy will be offered participation.
Subjects will receive CirvoTM compression therapy according to the standard of care protocol at NYU during or after surgery and 18 hours per day for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cirvo Device | Experimental | The CirvoTM device (Figure 1) is a lightweight, mobile, active, intermittent leg compression device placed on the calf of the leg, using hook and loop (e.g. Velcro) straps in the similar manner as commercially available intermittent leg compression devices The system utilizes an electro-mechanical drive system to intermittently compress the calf from the ankle toward the knee for a duration and compression level prescribed by the physician. The level of compression delivered by the CirvoTM therapy will be in the same range as existing devices which corresponds to the type of pressure applied by a blood pressure cuff. |
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| ActiveCare DVT | Active Comparator | A commercially available device was previously used to assess patient satisfaction with compression therapy for DVT prophylaxis as per standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Change in User interfaces of Cirvo compression device application. | Other | Comparison of 2 versions of the Circo user interface |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in compliance using Cirvo compression therapy | A sample size of 100 subjects is powered at 90% to show a difference of 10% in compliance between the 2 digital engagement cohorts. For each subject, Compliance will be calculated for each participant during the course of therapy in terms of the number of hours of actual use/number of hours of prescribed use. The number of hours will be summarized as days of use for each group. The means of each group will be presented. The primary endpoint is the difference in compliance between the group assigned to digital engagement versus no digital engagement with the Cirvo app. The mean difference will be compared to zero using the paired t-test | 14 day visit (+7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient satisfaction using Cirvo compression therapy | A comparison between the satisfaction of CirvoTM therapy versus the historical data from comparator device use will be performed. Results of the usability questionnaire (Patient Satisfaction Intermittent Compression Devices Questionnaire) will be qualitatively summarized. | 14 day visit (+7 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Slover, MD | NYU Langone Health | Principal Investigator |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Upon reasonable request
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data.Requests should be directed to Daniel.waren@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Change in Satisfaction in use of Cirvo device | Other | Comparison of how satisfied patients are with the Cirvo device to a different compression device (ActiveCare) |
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| Change in staff satisfaction using Cirvo compression therapy. | A comparison between the satisfaction of CirvoTM therapy versus the historical data from comparator device use will be performed. Results of the usability questionnaire will be qualitatively summarized. Staff Satisfaction Intermittent Compression Devices Questionnaire will be administered. | 14 day visit (+7 days) |
| Change in patients satisfaction using Cirvo compression therapy | A comparison between the satisfaction of CirvoTM therapy versus the historical data from comparator device use will be performed. Results of the usability questionnaire (Patient Satisfaction Intermittent Compression Devices Questionnaire) will be qualitatively summarized. | 30 day visit |