Total Knee Arthroplasty
Conditions
Keywords
Total knee arthroplasty, Physical therapy, Neuromuscular electrical stimulation, Telemedicine
Brief 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.
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.
Interventions
DEVICECyMedica e-vive™ System; CY-1000
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.
OTHERiGetBetter telemedicine physical therapy
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.
Sponsors
CyMedica Orthopedics, Inc
Wolfgang Fitz, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants assigned to one of three groups, there is no crossover. Participants remain in their assigned group until completion of study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sit-to-stand Time | Preoperative (varies) and postoperative appointments (2 months after surgery) | Change in sit-to-stand capabilities |
| Quadriceps Strength | 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 | Preoperative and postoperative appointments (2 months after surgery) | Change in distance walked in 2 minutes |
| Walking Speed | Preoperative and postoperative appointments (2 months after surgery) | Change in walking speed |
| Balancing | Preoperative and postoperative appointments (2 months after surgery) | Change in proprioception (balance) as measured by 30-second single limb stance PT test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) Pain | first postoperative months (from days post-op through 2-month post-operative appointment) | Change in Visual Analog Scale for pain (1-10) 1 no pain 10 worse |
| Cost Per Treatment Regimen (iGetBetter vs. CyMedica E-vive vs. Home PT) | Completion of study (anticipate one year from start data 4/4/2019) | We will calculate the total cost of each treatment modality |
| Visual Analogue Scale (VAS) Nausea | first postoperative months (from days post-op through 2-month post-operative appointment) | Change in VAS nausea (Visual Analog Scale for nausea (1-10) 1 no nausea 10 worse nausea ) |
| Visual Analogue Scale (VAS) Satisfaction | first postoperative months (from days post-op through 2-month post-operative appointment) | Change in VAS satisfaction (Visual Analog Scale for satisfaction (1-10) 1 not satisfied, 10 totally unsatisfied) |
| Readmission Rate | Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) | major complication |
| Infection Rate | Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery) | superficial and deep infection |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1, iGetBetter Group 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.
iGetBetter telemedicine physical therapy: 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. | 0 |
| Group 2, E-vive Group 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.
CyMedica e-vive™ System; CY-1000: 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. | 0 |
| Group 3, Physical Therapy Group 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. | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 |
| Overall Study | Study terminated due to low enrollment. | 7 | 5 | 7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 | 0 / 7 |
| other Total, other adverse events | 1 / 8 | 1 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 | 0 / 7 |
Outcome results
Primary
2 Minute Walking Time
Change in distance walked in 2 minutes
Time frame: Preoperative and postoperative appointments (2 months after surgery)
Population: Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.
Primary
Balancing
Change in proprioception (balance) as measured by 30-second single limb stance PT test
Time frame: Preoperative and postoperative appointments (2 months after surgery)
Population: Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.
Primary
Quadriceps Strength
Change in quadriceps strength in lbs of force, as measured by PT dynamometer
Time frame: Preoperative and postoperative appointments (2 months after surgery)
Population: Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.
Primary
Sit-to-stand Time
Change in sit-to-stand capabilities
Time frame: Preoperative (varies) and postoperative appointments (2 months after surgery)
Population: Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.
Primary
Walking Speed
Change in walking speed
Time frame: Preoperative and postoperative appointments (2 months after surgery)
Population: Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.
Secondary
Cost Per Treatment Regimen (iGetBetter vs. CyMedica E-vive vs. Home PT)
We will calculate the total cost of each treatment modality
Time frame: Completion of study (anticipate one year from start data 4/4/2019)
Population: Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.
Secondary
Infection Rate
superficial and deep infection
Time frame: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)
Population: Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.
Secondary
Readmission Rate
major complication
Time frame: Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery)
Population: Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.
Secondary
Visual Analogue Scale (VAS) Nausea
Change in VAS nausea (Visual Analog Scale for nausea (1-10) 1 no nausea 10 worse nausea )
Time frame: first postoperative months (from days post-op through 2-month post-operative appointment)
Population: Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.
Secondary
Visual Analogue Scale (VAS) Pain
Change in Visual Analog Scale for pain (1-10) 1 no pain 10 worse
Time frame: first postoperative months (from days post-op through 2-month post-operative appointment)
Population: Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.
Secondary
Visual Analogue Scale (VAS) Satisfaction
Change in VAS satisfaction (Visual Analog Scale for satisfaction (1-10) 1 not satisfied, 10 totally unsatisfied)
Time frame: first postoperative months (from days post-op through 2-month post-operative appointment)
Population: Due to limitations caused by COVID, enrollment targets could not be met. Data was not collected for targets that were enrolled. No analysis of population was performed because no data was collected and therefore cannot be reported.