Radial Medical - GAPS

NYU Langone Health

Status: Withdrawn

Conditions: Osteoarthritis

Treatments: Other: Change in User interfaces of Cirvo compression device application.; Other: Change in Satisfaction in use of Cirvo device

Study type: Interventional

Funder types: Other

Identifiers

NCT04163913

19-01399

Details and patient eligibility

About

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.

Full description

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.

1. Baseline: Following consent, participants will provide demographic, medical history and information with respect to their elective orthopedic procedure and receive training on the CirvoTM device. Participants will be randomized to either digital engagement or no digital engagement groups.
2. Post procedure: After the procedure, CirvoTM device operation will be reviewed with the participant.
3. Discharge: Any adverse events occurring during hospitalization will be reviewed, data capture on the CirvoTM app will be confirmed.
4. 14- day visit: Participants will complete a patient satisfaction questionnaire, provide information with respect to any adverse events including specific details about DVT and readmission and return the devices.
5. 30-day phone call/visit: Participants will be contacted at 30 days to answer questions about DVT's and readmissions.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female over the age of 18
• Undergoing elective primary total hip/knee replacement
• Planned discharge to home
• Able to train to and operate the Cirvo device with app

Exclusion criteria

• History of Pulmonary Embolism
• Active cancer
• BMI >40
• Current smoker
• History of a hyper-coaguable condition
• Actual or expected prolonged bedrest for >3 days
• Calf geometry on which Cirvo device does not appropriately fit (prospective cohort only)
• Known sensitivity to any of the materials used in the Cirvo device (prospective cohort only)
• Currently participating or planning to participate in any other investigational clinical evaluation during study period that may, in the opinion of the investigator, affect compliance (prospective cohort only)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Cirvo Device

Experimental group

Description:

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.

Treatment:

Other: Change in User interfaces of Cirvo compression device application.

Other: Change in Satisfaction in use of Cirvo device

ActiveCare DVT

Active Comparator group

Description:

A commercially available device was previously used to assess patient satisfaction with compression therapy for DVT prophylaxis as per standard of care.

Treatment:

Other: Change in User interfaces of Cirvo compression device application.

Other: Change in Satisfaction in use of Cirvo device