N/A
N=106
Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance
Orthopedic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04995601 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Compliance to Prescribed Use — 67.7; 83.3 percentage of prescribed use/24hr
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RF Health MAC (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Recovery Force LLC
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compliance to Prescribed Use |
67.7; 83.3 | — |
| PRIMARY Patient-reported Comfort |
3.1; 3.5 | — |
| PRIMARY Patient-reported Ease-of-use |
2.6; 2.3 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT04995601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.