Trial Outcomes & Findings for Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty (NCT NCT04060251)
NCT ID: NCT04060251
Last Updated: 2023-06-07
Results Overview
Change in sit-to-stand capabilities
TERMINATED
NA
21 participants
Preoperative (varies) and postoperative appointments (2 months after surgery)
2023-06-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
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|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Study terminated due to low enrollment.
|
7
|
5
|
7
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
Baseline Characteristics
Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 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.
Change in sit-to-stand capabilities
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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.
Change in quadriceps strength in lbs of force, as measured by PT dynamometer
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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.
Change in distance walked in 2 minutes
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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.
Change in walking speed
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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.
Change in proprioception (balance) as measured by 30-second single limb stance PT test
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Change in Visual Analog Scale for pain (1-10) 1 no pain 10 worse
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Change in VAS nausea (Visual Analog Scale for nausea (1-10) 1 no nausea 10 worse nausea )
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Change in VAS satisfaction (Visual Analog Scale for satisfaction (1-10) 1 not satisfied, 10 totally unsatisfied)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
major complication
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
superficial and deep infection
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
We will calculate the total cost of each treatment modality
Outcome measures
Outcome data not reported
Adverse Events
Group 1, iGetBetter Group
Group 2, E-vive Group
Group 3, Physical Therapy Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1, iGetBetter Group
n=8 participants at risk
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.
|
Group 2, E-vive Group
n=6 participants at risk
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.
|
Group 3, Physical Therapy Group
n=7 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Advanced Home PT Required
|
12.5%
1/8 • Number of events 1 • 148 days (21.14 weeks)
|
16.7%
1/6 • Number of events 1 • 148 days (21.14 weeks)
|
0.00%
0/7 • 148 days (21.14 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place