Clinical Trials Logo

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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04995601
Study type Interventional
Source Recovery Force LLC
Contact
Status Completed
Phase N/A
Start date April 1, 2022
Completion date March 31, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05864833 - METabolism After Orthopedic Surgery
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Recruiting NCT05461326 - Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT N/A
Completed NCT06080685 - Efficacy of Character Strengths Intervention in Enhancing Character Strengths and Self-esteem Among Adolescents N/A
Not yet recruiting NCT06326827 - In'Oss™ (MBCP® Putty) Ortho
Not yet recruiting NCT06002009 - SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function
Completed NCT04730115 - Evaluation of Architectural Changes in Mandibular Bone Pattern After Functional Treatment by Fractal Dimension Analysis
Withdrawn NCT03436667 - Perioperative Factors Impacting Surgical Risk and Outcomes in Children
Completed NCT03299920 - Opioid Consumption After Knee Arthroscopy N/A
Active, not recruiting NCT05075525 - EFFECT OF HIGH INTENSITY LASER IN PATELLOFEMORAL PAIN SYNDROME N/A
Completed NCT06158165 - Evaluating The Cardiovascular Effects of Tourniquet Application
Recruiting NCT04891549 - Tension Band Versus Locking Plate Fixation for the Treatment of Patella Fractures N/A
Recruiting NCT04676841 - Wound Contamination During Orthopaedic Surgery
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT04514601 - A Quality Improvement Project to Assess and Refine the Handover Process at Morning Trauma Meetings
Not yet recruiting NCT04546594 - Epidemiological Data on Pain
Completed NCT05396924 - Rectal Temperature Measurement in Detecting Hypothermia During Hip Arthroscopy N/A
Active, not recruiting NCT06438835 - Development & Evaluation of Pneumatic Artificial Muscle(PAM) for Patients With Ankle Foot Orthosis(AFO) N/A
Active, not recruiting NCT05795127 - Risk for Reoperation After First MTP Joint Arthrodesis
Completed NCT04481711 - Total Knee Arthroplasty and Clinical Findings N/A