Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance
Condition: Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

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.
    

Intervention name(s): RF Health MAC
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment