Clinical trial NCT04995601: Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance
Official title: Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Lead sponsor: Recovery Force LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Massachusetts, Amherst
First posted: 2021-08-09
Enrollment: 106
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Compliance to Prescribed Use
timeFrame: day 1 postoperative joint replacement
measure: Patient-reported Comfort
timeFrame: at the end of 14-day data collection period
measure: Patient-reported Ease-of-use
timeFrame: at the end of 14-day data collection period
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts
state: Massachusetts
Study officials:
References: