Orthopedic DisorderSBIR2NCT04995601
Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance
A study testing RF Health MAC in people with Orthopedic Disorder, run by Recovery Force LLC at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- RF Health MAC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Orthopedic Disorder
- Being tested
- RF Health MAC
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF Health MACDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants will receive DVT prophylaxis using standard intermittent pneumatic compression during postoperative care after total joint replacement. |
| Recovery Force MAC | Experimental | Participants will receive DVT prophylaxis using the RF Health MAC during postoperative care after total joint replacement. Receives: Device: RF Health MAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to Prescribed Use
Compare patient compliance (percentage of prescribed use/24hr) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients.
Measured: day 1 postoperative joint replacement
Patient-reported Comfort
Compare patient-reported comfort (patient reported outcomes in the hospital-standard of care vs RF MAC-for overall comfort, where higher score is better device performance (5-pt Likert Scale; 1=Strongly disagree, 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly Agree) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients.
Measured: at the end of 14-day data collection period
Patient-reported Ease-of-use
Compare patient-reported ease-of-use (using the System Usability Scale, with a range of 0-21, where higher score =higher ease of use) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients.
Measured: at the end of 14-day data collection period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Apr 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recovery Force LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Massachusetts, Amherst
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995601
- Sponsor's protocol ID
- TP1400-04
- Acronym
- SBIR2
- Status last verified
- Apr 2023
- First submitted
- 29 May 2021
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance
- ClinicalTrials.gov ID
- NCT04995601
- Acronym / sponsor ID
- SBIR2 / TP1400-04
- Conditions
- Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Recovery Force LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Massachusetts, Amherst
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants will receive DVT prophylaxis using standard intermittent pneumatic compression during postoperative care after total joint replacement. |
| Recovery Force MAC | Experimental | Device: RF Health MACParticipants will receive DVT prophylaxis using the RF Health MAC during postoperative care after total joint replacement. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF Health MACThe 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. | Device | Recovery Force MAC |
Primary outcome
Compliance to Prescribed Use
Time frame: day 1 postoperative joint replacement
Compare patient compliance (percentage of prescribed use/24hr) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients.
Patient-reported Comfort
Time frame: at the end of 14-day data collection period
Compare patient-reported comfort (patient reported outcomes in the hospital-standard of care vs RF MAC-for overall comfort, where higher score is better device performance (5-pt Likert Scale; 1=Strongly disagree, 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly Agree) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients.
Patient-reported Ease-of-use
Time frame: at the end of 14-day data collection period
Compare patient-reported ease-of-use (using the System Usability Scale, with a range of 0-21, where higher score =higher ease of use) between the standard of care sequential compression device and the Recovery Force Mobility and Compression (MAC) system in a group of total joint replacement patients.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Orthopedic Disorder
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF Health MAC in people with Orthopedic Disorder, run by Recovery Force LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to Prescribed Use (time frame: day 1 postoperative joint replacement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.