Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance

NCT04995601 | Completed Results FDA Device

• 1 other identifier: TP1400-04
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Device: RF Health MAC

Interventions

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.

Recovery Force MAC

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients (age 40-85)
• first elective total hip replacement (THR) or first or second (opposite knee) elective total knee replacement (TKA
• speak English
• expected to have a hospital stay of two days or less
• discharge to home from hospital (not a rehabilitation facility)
• must be able to perform self-care
• BMI between 18 and 39
• calf circumference between 11 and 24.5 inches

You may not qualify if:

• partial joint replacement, TJR revisions, emergency surgeries
• calf deformities that would not allow proper fit for external compression device
• non-ambulatory
• clinically malnourished or frail/deconditioned
• vulnerable patients (pregnant women, prisoners, homeless and cognitively impaired)
• do not speak English

Sponsors & Collaborators

• Recovery Force LLC: lead
• University of Massachusetts, Amherst: collaborator

Study Sites (1)

Tufts

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Limitations and Caveats

Due to COVID and one of the sites losing their most high volume orthopedic surgeon, this trial was significantly under-enrolled and underpowered

Results Point of Contact

• Title: Jeff Schwegman (PI), Dr. Karen Giuliano (PI, clinical trial subaward)
• Organization: Recovery Force Health, University of Massachusetts Amherst

kschwegman@recoveryforceusa.com; kkgiuliano@umass.edu

317-605-4696; 224-725-0270

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2021
• First Posted: August 9, 2021
• Study Start: April 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)