Total Knee ArthroplastyNCT04060251
Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty
A study testing CyMedica e-vive™ System; CY-1000 and iGetBetter telemedicine physical therapy in people with Total Knee Arthroplasty, run by Wolfgang Fitz, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how different pre-operative therapeutic approaches affect quad strength and patient satisfaction after total knee replacements. There are three treatments groups: standard physical therapy protocol, the use of CyMedica NMES garments, and a telemedical home therapy program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- CyMedica e-vive™ System; CY-1000 and iGetBetter telemedicine physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 17 Jan 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Owns a device with internet connection
- Can download the E-vive application for the contractile garment (has sufficiently up-to-date phone or tablet, or has family member with such a device).
- Has a rudimentary understanding of Internet technology, especially e-mail
- Has a flexion of 90 o and flexion contracture of 5 o at the point of discharge
- Approved by a physical therapist to participate safely in the study at the time of discharge
Who cannot join
- Rheumatoid arthritis
- History of epilepsy
- Implanted and body-worn electronic medical device, including cardiac pacemakers, neural stimulators, insulin pumps, etc.
- Poor understanding of the use of the brace/electrical stimulation
- Lesions on the skin over the thigh
- Uncontrolled diabetes
Show all 17Show fewer
- Uncontrolled hypertension
- Bilateral TKA or UKA planned
- If female, pregnant
- Cannot use non-operated leg postoperatively to propel active motion splint, caused by neurological or muscular diseases such as complete or incomplete paralysis or other causes of weakness with an inability to bend or extend knee
- Loss of sensation in operated or non-operated leg
- Has below- or above-knee amputations of non-operative leg
- Below- knee amputation of operated side
- Chronic pain syndrome with inability to walk
- Taking chronic narcotics and/or is taking more than 10mg codeine per day, or any Hydrocodone, or more than 200 mg of tramadol, or any other narcotics prescribed for moderate to severe pain
- Involved in pain clinics for chronic pain, or pain that is not related to the knee
- Has been diagnosed with knee disorder other than osteoarthritis, post-traumatic osteoarthritis, gout, pseudo gout, or any inability to walk due to disorders unrelated to the knee (e.g., hip disorders, spinal stenosis, paralysis, hemi-paralysis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
About this study
The purpose of this study is to evaluate how different pre-operative therapeutic approaches affect quad strength and patient satisfaction after total knee replacements. There are three treatments groups: standard physical therapy protocol, the use of CyMedica NMES garments, and a telemedical home therapy program.
Read the detailed description
Patients undergoing total knee replacement (TKR) at Brigham and Women's Faulkner Hospital and meet all eligibility criteria will be informed about the study and asked if they would like to participate. The research assistant (RA) will screen upcoming surgeries and call all qualifying patients to inform them of the study. Those who show interest will be offered the opportunity to discuss with both the RA and Principal Investigator (PI). Upon agreement, the patient's consent will be obtained and they will be randomly assigned to one of three treatment groups using a computer-generated randomization.
- Conditions
- Total Knee Arthroplasty
- Being tested
- CyMedica e-vive™ System; CY-1000, iGetBetter telemedicine physical therapy
- Keywords
- Total knee arthroplasty, Physical therapy, Neuromuscular electrical stimulation, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyMedica e-vive™ System; CY-1000Device
Also called Powered Muscle Stimulator or Neuromuscular Electrical Stimulator (NMES); IPF Transcutaneous Nerve Stimulator (TENS) for pain relief; GZJ Goniometer; KQX
All the patients in Group 2 will be given the CyMedica Orthopedics e-vive system 3 weeks before the surgery. The patients will begin using the unit after their first pre-intervention measurements are taken.
Patients will be instructed to apply the e-vive NMES Strength therapy twice a day, 5 days a week. The NMES Strength program is 20 minutes in length. Treatment intensity (adjustable from 1 to 100 in NMES programs) is required to be set at the highest tolerable limit for the patients.
Stimulation from the garment will have the following parameters: frequency of 50 Hz; pulse duration of 5 ms; time on: 12.8 seconds; and time off: 10 seconds. The total contraction time in a 20-minute treatment will be 11 minutes. The waveform will be pulsed and asymmetrical.
iGetBetter telemedicine physical therapyOther
Group 1 patients will only use a Post-Op program from iGetBetter for the first 3 weeks after surgery. After those 3 weeks have elapsed, Group 1 patients will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks as all other groups.
| Study group | Role | What they receive |
|---|---|---|
| Group 1, iGetBetter Group | Experimental | Use only iGetBetter for the 3 months preceding surgery. After surgery, you will be given a new, Post-Op program to use for 2-3 months. For the first 3 weeks, you will only use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks. Receives: Other: iGetBetter telemedicine physical therapy |
| Group 2, E-vive Group | Experimental | You will use iGetBetter starting 3 months out from surgery. You will receive CyMedica's electrical-stimulation garment during the preoperative appointment. In addition to iGetBetter, you will wear the conductive garment two times each day for the last 3 weeks before surgery. After surgery, for the first 3 weeks you will only use the conductive garment, and will not use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to wearing the brace, approximately twice per week for the next 6-8 weeks. You will not need to return the brace after this time is up, and you may keep the brace, if you so choose, at no cost. Receives: Device: CyMedica e-vive™ System; CY-1000 |
| Group 3, Physical Therapy Group | No intervention | You will receive only iGetBetter for the 3 months preceding surgery. After surgery, you will receive only home physical therapy, and will not use iGetBetter. After those three weeks, you will receive outpatient physical therapy approximately twice per week for the next 6-8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit-to-stand Time
Change in sit-to-stand capabilities
Measured: Preoperative (varies) and postoperative appointments (2 months after surgery)
Quadriceps Strength
Change in quadriceps strength in lbs of force, as measured by PT dynamometer
Measured: Preoperative and postoperative appointments (2 months after surgery)
2 Minute Walking Time
Change in distance walked in 2 minutes
Measured: Preoperative and postoperative appointments (2 months after surgery)
Walking Speed
Change in walking speed
Measured: Preoperative and postoperative appointments (2 months after surgery)
Balancing
Change in proprioception (balance) as measured by 30-second single limb stance PT test
Measured: Preoperative and postoperative appointments (2 months after surgery)
Secondary outcomes (6)
Visual Analogue Scale (VAS) Pain
Change in Visual Analog Scale for pain (1-10) 1 no pain 10 worse
Measured: first postoperative months (from days post-op through 2-month post-operative appointment)
Visual Analogue Scale (VAS) Nausea
Change in VAS nausea (Visual Analog Scale for nausea (1-10) 1 no nausea 10 worse nausea )
Measured: first postoperative months (from days post-op through 2-month post-operative appointment)
Visual Analogue Scale (VAS) Satisfaction
Change in VAS satisfaction (Visual Analog Scale for satisfaction (1-10) 1 not satisfied, 10 totally unsatisfied)
Measured: first postoperative months (from days post-op through 2-month post-operative appointment)
Readmission Rate
major complication
Measured: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)
Infection Rate
superficial and deep infection
Measured: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)
Cost Per Treatment Regimen (iGetBetter vs. CyMedica E-vive vs. Home PT)
We will calculate the total cost of each treatment modality
Measured: Completion of study (anticipate one year from start data 4/4/2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start4 Apr 2019
- Primary completion17 Jan 2022
- Study completion17 Jan 2022
Why it stopped: Due to limitations caused by COVID, enrollment targets could not be met.
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 Total Knee ArthroplastyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants assigned to one of three groups, there is no crossover. Participants remain in their assigned group until completion of study.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfgang Fitz, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- CyMedica Orthopedics, Inc
- Responsible party
- Sponsor-investigator, Wolfgang Fitz, M.D., Brigham and Women's Hospital
- Investigators
- Wolfgang Fitz, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060251
- Sponsor's protocol ID
- 2018P000932
- Status last verified
- May 2023
- First submitted
- 3 Apr 2019
- Last updated
- 7 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04060251
- Acronym / sponsor ID
- 2018P000932
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total knee arthroplasty, Physical therapy, Neuromuscular electrical stimulation, Telemedicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to limitations caused by COVID, enrollment targets could not be met.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wolfgang Fitz, M.D.University, hospital or other
- Collaborators
- CyMedica Orthopedics, Inc
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Posted 7 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate how different pre-operative therapeutic approaches affect quad strength and patient satisfaction after total knee replacements. There are three treatments groups: standard physical therapy protocol, the use of CyMedica NMES garments, and a telemedical home therapy program.
Detailed description
Patients undergoing total knee replacement (TKR) at Brigham and Women's Faulkner Hospital and meet all eligibility criteria will be informed about the study and asked if they would like to participate. The research assistant (RA) will screen upcoming surgeries and call all qualifying patients to inform them of the study. Those who show interest will be offered the opportunity to discuss with both the RA and Principal Investigator (PI). Upon agreement, the patient's consent will be obtained and they will be randomly assigned to one of three treatment groups using a computer-generated randomization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants assigned to one of three groups, there is no crossover. Participants remain in their assigned group until completion of study.
| Arm | Type | Receives |
|---|---|---|
| Group 1, iGetBetter Group | Experimental | Other: iGetBetter telemedicine physical therapyUse only iGetBetter for the 3 months preceding surgery. After surgery, you will be given a new, Post-Op program to use for 2-3 months. For the first 3 weeks, you will only use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks. |
| Group 2, E-vive Group | Experimental | Device: CyMedica e-vive™ System; CY-1000You will use iGetBetter starting 3 months out from surgery. You will receive CyMedica's electrical-stimulation garment during the preoperative appointment. In addition to iGetBetter, you will wear the conductive garment two times each day for the last 3 weeks before surgery. After surgery, for the first 3 weeks you will only use the conductive garment, and will not use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to wearing the brace, approximately twice per week for the next 6-8 weeks. You will not need to return the brace after this time is up, and you may keep the brace, if you so choose, at no cost. |
| Group 3, Physical Therapy Group | No intervention | –You will receive only iGetBetter for the 3 months preceding surgery. After surgery, you will receive only home physical therapy, and will not use iGetBetter. After those three weeks, you will receive outpatient physical therapy approximately twice per week for the next 6-8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older
- Owns a device with internet connection
- Can download the E-vive application for the contractile garment (has sufficiently up-to-date phone or tablet, or has family member with such a device).
- Has a rudimentary understanding of Internet technology, especially e-mail
- Has a flexion of 90 o and flexion contracture of 5 o at the point of discharge
Key exclusion criteria (17 listed)
- Rheumatoid arthritis
- History of epilepsy
- Implanted and body-worn electronic medical device, including cardiac pacemakers, neural stimulators, insulin pumps, etc.
- Poor understanding of the use of the brace/electrical stimulation
- Lesions on the skin over the thigh
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 |
|---|---|---|
| CyMedica e-vive™ System; CY-1000Also: Powered Muscle Stimulator or Neuromuscular Electrical Stimulator (NMES); IPF Transcutaneous Nerve Stimulator (TENS) for pain relief; GZJ Goniometer; KQXAll the patients in Group 2 will be given the CyMedica Orthopedics e-vive system 3 weeks before the surgery. The patients will begin using the unit after their first pre-intervention measurements are taken. Patients will be instructed to apply the e-vive NMES Strength therapy twice a day, 5 days a week. The NMES Strength program is 20 minutes in length. Treatment intensity (adjustable from 1 to 100 in NMES programs) is required to be set at the highest tolerable limit for the patients. Stimulation from the garment will have the following parameters: frequency of 50 Hz; pulse duration of 5 ms; time on: 12.8 seconds; and time off: 10 seconds. The total contraction time in a 20-minute treatment will be 11 minutes. The waveform will be pulsed and asymmetrical. | Device | Group 2, E-vive Group |
| iGetBetter telemedicine physical therapyGroup 1 patients will only use a Post-Op program from iGetBetter for the first 3 weeks after surgery. After those 3 weeks have elapsed, Group 1 patients will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks as all other groups. | Other | Group 1, iGetBetter Group |
Primary outcome
Sit-to-stand Time
Time frame: Preoperative (varies) and postoperative appointments (2 months after surgery)
Change in sit-to-stand capabilities
Quadriceps Strength
Time frame: Preoperative and postoperative appointments (2 months after surgery)
Change in quadriceps strength in lbs of force, as measured by PT dynamometer
2 Minute Walking Time
Time frame: Preoperative and postoperative appointments (2 months after surgery)
Change in distance walked in 2 minutes
Walking Speed
Time frame: Preoperative and postoperative appointments (2 months after surgery)
Change in walking speed
Balancing
Time frame: Preoperative and postoperative appointments (2 months after surgery)
Change in proprioception (balance) as measured by 30-second single limb stance PT test
6 secondary outcomes
Visual Analogue Scale (VAS) Pain
Time frame: first postoperative months (from days post-op through 2-month post-operative appointment)
Visual Analogue Scale (VAS) Nausea
Time frame: first postoperative months (from days post-op through 2-month post-operative appointment)
Visual Analogue Scale (VAS) Satisfaction
Time frame: first postoperative months (from days post-op through 2-month post-operative appointment)
Readmission Rate
Time frame: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)
Infection Rate
Time frame: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)
Cost Per Treatment Regimen (iGetBetter vs. CyMedica E-vive vs. Home PT)
Time frame: Completion of study (anticipate one year from start data 4/4/2019)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers.
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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.
Wolfgang Fitz, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyMedica e-vive™ System; CY-1000 and iGetBetter telemedicine physical therapy in people with Total Knee Arthroplasty, run by Wolfgang Fitz, M.D. 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 6 inclusion and 17 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: stopped early, as of the sponsor's last update on 7 Jun 2023. 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 7 Jun 2023). 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?
Sit-to-stand Time (time frame: Preoperative (varies) and postoperative appointments (2 months after surgery)). The study lists 5 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 7 Jun 2023.