Trial Outcomes & Findings for Neuromuscular Electrical Stimulation (NMES) for Improving Outcomes Following Total Knee Arthroplasty (TKA) (NCT NCT03044028)
NCT ID: NCT03044028
Last Updated: 2020-03-05
Results Overview
measure change in muscle strength (QFM) - difference from baseline measure to 6 weeks postoperative
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
6 weeks
Results posted on
2020-03-05
Participant Flow
Participant milestones
| Measure |
NMES Preoperative and Postoperative
Subject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use preoperative and will continue to use postoperatively until end of study
CyMedica Orthopedics QB1 e-vive™ system: a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES), for improving quadriceps strength and improving functional outcomes accelerating functional recovery in patients managed with total knee arthroplasty (TKA).
|
NMES Postoperative Only
Subject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use postoperatively and will continue to use until end of study
CyMedica Orthopedics QB1 e-vive™ system: a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES), for improving quadriceps strength and improving functional outcomes accelerating functional recovery in patients managed with total knee arthroplasty (TKA).
|
No Intervention
Subject will not be given device and will undergo the standard rehab protocol alone
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
22
|
|
Overall Study
COMPLETED
|
12
|
12
|
22
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race not collected
Baseline characteristics by cohort
| Measure |
NMES Preoperative and Postoperative
n=12 Participants
Subject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use preoperative and will continue to use postoperatively until end of study
CyMedica Orthopedics QB1 e-vive™ system: a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES), for improving quadriceps strength and improving functional outcomes accelerating functional recovery in patients managed with total knee arthroplasty (TKA).
|
NMES Postoperative Only
n=12 Participants
Subject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use postoperatively and will continue to use until end of study
CyMedica Orthopedics QB1 e-vive™ system: a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES), for improving quadriceps strength and improving functional outcomes accelerating functional recovery in patients managed with total knee arthroplasty (TKA).
|
No Intervention
n=22 Participants
Subject will not be given device and will undergo the standard rehab protocol alone
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 5.2 • n=12 Participants
|
66.6 years
STANDARD_DEVIATION 6.3 • n=12 Participants
|
64.5 years
STANDARD_DEVIATION 7.6 • n=22 Participants
|
64.9 years
STANDARD_DEVIATION 6.7 • n=46 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=12 Participants
|
9 Participants
n=12 Participants
|
17 Participants
n=22 Participants
|
35 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
5 Participants
n=22 Participants
|
11 Participants
n=46 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
—
|
0 Participants
Race not collected
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
—
|
0 Participants
Race not collected
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
0 Participants
Race not collected
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
—
|
0 Participants
Race not collected
|
|
Race (NIH/OMB)
White
|
—
|
—
|
—
|
0 Participants
Race not collected
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
—
|
0 Participants
Race not collected
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
0 Participants
Race not collected
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
22 participants
n=22 Participants
|
46 participants
n=46 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Numbers do not match Participant Flow because data were missing.
measure change in muscle strength (QFM) - difference from baseline measure to 6 weeks postoperative
Outcome measures
| Measure |
NMES Preoperative and Postoperative
n=11 Participants
NMES Preoperative and Postoperative, patients used the device a minimum of 900 minutes total preoperatively, and 200 min/wk postoperatively
|
NMES Postoperative Only
n=10 Participants
NMES Postoperative only, patients used the device a minimum of 200 min/wk postoperatively
|
Control - no NMES
n=16 Participants
Control - no NMES, patients did not use the device
|
|---|---|---|---|
|
Quadriceps Femoris Muscle (QFM) Strength (Dynamometer Quad Strength Lbs)
|
3.35 lbs
Standard Deviation 20.70
|
15.95 lbs
Standard Deviation 14.61
|
-5.48 lbs
Standard Deviation 16.53
|
SECONDARY outcome
Timeframe: 12 weeksMeasure rage of motion differences between the treatment groups
Outcome measures
| Measure |
NMES Preoperative and Postoperative
n=12 Participants
NMES Preoperative and Postoperative, patients used the device a minimum of 900 minutes total preoperatively, and 200 min/wk postoperatively
|
NMES Postoperative Only
n=12 Participants
NMES Postoperative only, patients used the device a minimum of 200 min/wk postoperatively
|
Control - no NMES
n=22 Participants
Control - no NMES, patients did not use the device
|
|---|---|---|---|
|
Knee Active Range of Motion (Extension, Flexion) in Degrees
|
0.50 degrees
Standard Deviation 13.22
|
6.67 degrees
Standard Deviation 15.40
|
-1.50 degrees
Standard Deviation 12.93
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Numbers do not match Participant Flow because data were missing.
Differences in VAS scores between the treatment groups from baseline to 12 weeks postop. Higher score represents worse pain.
Outcome measures
| Measure |
NMES Preoperative and Postoperative
n=12 Participants
NMES Preoperative and Postoperative, patients used the device a minimum of 900 minutes total preoperatively, and 200 min/wk postoperatively
|
NMES Postoperative Only
n=10 Participants
NMES Postoperative only, patients used the device a minimum of 200 min/wk postoperatively
|
Control - no NMES
n=22 Participants
Control - no NMES, patients did not use the device
|
|---|---|---|---|
|
Visual Analogue Scale (VAS) Pain Level (0-10 Scale)
|
2.00 units on a scale
Standard Deviation 2.92
|
1.80 units on a scale
Standard Deviation 2.04
|
1.18 units on a scale
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: 12 weeksdifferences in length of stay between the treatment groups
Outcome measures
| Measure |
NMES Preoperative and Postoperative
n=12 Participants
NMES Preoperative and Postoperative, patients used the device a minimum of 900 minutes total preoperatively, and 200 min/wk postoperatively
|
NMES Postoperative Only
n=12 Participants
NMES Postoperative only, patients used the device a minimum of 200 min/wk postoperatively
|
Control - no NMES
n=22 Participants
Control - no NMES, patients did not use the device
|
|---|---|---|---|
|
Hospital Length of Stay (Days)
|
1.83 days
Standard Deviation 0.72
|
1.75 days
Standard Deviation 0.45
|
1.68 days
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: 12 weeksPatent discharge other than "home" to extended care facility
Outcome measures
| Measure |
NMES Preoperative and Postoperative
n=12 Participants
NMES Preoperative and Postoperative, patients used the device a minimum of 900 minutes total preoperatively, and 200 min/wk postoperatively
|
NMES Postoperative Only
n=12 Participants
NMES Postoperative only, patients used the device a minimum of 200 min/wk postoperatively
|
Control - no NMES
n=22 Participants
Control - no NMES, patients did not use the device
|
|---|---|---|---|
|
Number of Patients Discharged to Extended Care Facility
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksNumber of all-cause readmissions to the hospital
Outcome measures
| Measure |
NMES Preoperative and Postoperative
n=12 Participants
NMES Preoperative and Postoperative, patients used the device a minimum of 900 minutes total preoperatively, and 200 min/wk postoperatively
|
NMES Postoperative Only
n=12 Participants
NMES Postoperative only, patients used the device a minimum of 200 min/wk postoperatively
|
Control - no NMES
n=22 Participants
Control - no NMES, patients did not use the device
|
|---|---|---|---|
|
Number of Patients Readmitted to Hospital
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksDifference in number of outpatient therapy visits among the treatment groups
Outcome measures
| Measure |
NMES Preoperative and Postoperative
n=7 Participants
NMES Preoperative and Postoperative, patients used the device a minimum of 900 minutes total preoperatively, and 200 min/wk postoperatively
|
NMES Postoperative Only
n=8 Participants
NMES Postoperative only, patients used the device a minimum of 200 min/wk postoperatively
|
Control - no NMES
n=21 Participants
Control - no NMES, patients did not use the device
|
|---|---|---|---|
|
Number of Outpatient Therapy Visits (Patient Questionnaire)
|
12.86 visits
Standard Deviation 4.95
|
16.25 visits
Standard Deviation 7.29
|
11.67 visits
Standard Deviation 5.06
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Numbers do not match Participant Flow because data were missing.
Functional outcomes using the Knee Injury and Osteoarthritis Outcome Score (KOOS) Physical Function Shortform (PS) questionnaire. Change in total score from baseline to 12 weeks postoperative score. Minimum value is 0, maximum value is 100, and higher values mean greater improvement over baseline total score.
Outcome measures
| Measure |
NMES Preoperative and Postoperative
n=9 Participants
NMES Preoperative and Postoperative, patients used the device a minimum of 900 minutes total preoperatively, and 200 min/wk postoperatively
|
NMES Postoperative Only
n=10 Participants
NMES Postoperative only, patients used the device a minimum of 200 min/wk postoperatively
|
Control - no NMES
n=16 Participants
Control - no NMES, patients did not use the device
|
|---|---|---|---|
|
KOOS - PS
|
33.43 units on a scale
Standard Deviation 14.76
|
20.39 units on a scale
Standard Deviation 12.70
|
26.62 units on a scale
Standard Deviation 9.81
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Numbers do not match Participant Flow because data were missing.
Measure pain at 12 weeks postoperative using Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscore. Change in total score from baseline to 12 weeks postoperative score. Minimum value is 0, maximum value is 100, and higher values mean greater improvement over baseline total score.
Outcome measures
| Measure |
NMES Preoperative and Postoperative
n=9 Participants
NMES Preoperative and Postoperative, patients used the device a minimum of 900 minutes total preoperatively, and 200 min/wk postoperatively
|
NMES Postoperative Only
n=10 Participants
NMES Postoperative only, patients used the device a minimum of 200 min/wk postoperatively
|
Control - no NMES
n=16 Participants
Control - no NMES, patients did not use the device
|
|---|---|---|---|
|
KOOS Pain
|
72.22 z-score
Standard Deviation 19.64
|
78.89 z-score
Standard Deviation 16.57
|
80.38 z-score
Standard Deviation 15.43
|
Adverse Events
NMES Preoperative and Postoperative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NMES Postoperative Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - no NMES
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NMES Preoperative and Postoperative
n=22 participants at risk
NMES Preoperative and Postoperative, patients used the device a minimum of 900 minutes total preoperatively, and 200 min/wk postoperatively
|
NMES Postoperative Only
n=22 participants at risk
NMES Postoperative only, patients used the device a minimum of 200 min/wk postoperatively
|
Control - no NMES
n=22 participants at risk
Control - no NMES, patients did not use the device
|
|---|---|---|---|
|
Gastrointestinal disorders
Readmission
|
0.00%
0/22 • Adverse event data were collected through 12 weeks postoperative.
|
0.00%
0/22 • Adverse event data were collected through 12 weeks postoperative.
|
4.5%
1/22 • Number of events 1 • Adverse event data were collected through 12 weeks postoperative.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place