Orthopedic Disorder Clinical Trial
Official title:
Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance
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).
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. ;
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 |