Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04995601 |
| Other study ID # |
TP1400-04 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
March 31, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Recovery Force LLC |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
