Trial Outcomes & Findings for Early Postoperative Compex Rehab NMES Use for Total Knee Arthroplasty Patients (NCT NCT01844193)

NCT ID: NCT01844193

Last Updated: 2021-04-12

Results Overview

Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 1-year postoperative follow-up minus the average quadriceps force measurement at baseline. Averages are stratified by study arm. Negative values indicate a reduction in quadriceps force from baseline measurement to 1-year.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline and 1-year Follow-up
• Results posted on: 2021-04-12

Participant Flow

60 patients were consented, but due to the gap between the consenting appointment and the baseline appointment, many patients failed to complete their baseline appointment or rescheduled/canceled their surgeries. Only patients attending the baseline appointment were considered enrolled.

Participant milestones

Measure	Standard Therapy This arm of the study will follow the standard therapy course after total knee arthroplasty.	Standard Therapy + NMES This arm will follow the standard course of therapy but also incorporate daily neuromuscular electrical stimulation into the daily therapy regimen after total knee arthroplasty through use of the Compex Rehab device. Compex Rehab: Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment ("Warm-up", "Work", "Relaxation", and "Recovery") for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated.
Overall Study STARTED	19	21
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Standard Therapy n=19 Participants This arm of the study will follow the standard therapy course after total knee arthroplasty.	Standard Therapy + NMES n=21 Participants This arm will follow the standard course of therapy but also incorporate daily neuromuscular electrical stimulation into the daily therapy regimen after total knee arthroplasty through use of the Compex Rehab device. Compex Rehab: Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment ("Warm-up", "Work", "Relaxation", and "Recovery") for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated.	Total n=40 Participants Total of all reporting groups
Age, Continuous	61 years n=19 Participants	62 years n=21 Participants	62 years n=40 Participants
Sex: Female, Male Female	10 Participants n=19 Participants	7 Participants n=21 Participants	17 Participants n=40 Participants
Sex: Female, Male Male	9 Participants n=19 Participants	14 Participants n=21 Participants	23 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Quad Force	276.8 Newtons (N) n=19 Participants	291.1 Newtons (N) n=21 Participants	282.38 Newtons (N) n=40 Participants

PRIMARY outcome

Timeframe: Baseline and 1-year Follow-up

Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 1-year postoperative follow-up minus the average quadriceps force measurement at baseline. Averages are stratified by study arm. Negative values indicate a reduction in quadriceps force from baseline measurement to 1-year.

Outcome measures

Measure	Standard Therapy n=19 Participants This arm of the study will follow the standard therapy course after total knee arthroplasty.	Standard Therapy + NMES n=21 Participants This arm will follow the standard course of therapy but also incorporate daily neuromuscular electrical stimulation into the daily therapy regimen after total knee arthroplasty through use of the Compex Rehab device. Compex Rehab: Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment ("Warm-up", "Work", "Relaxation", and "Recovery") for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated.
Change in Quadriceps Force	49.0 Newtons (N) Interval -175.92 to 128.92	28.4 Newtons (N) Interval -172.3 to 116.4

SECONDARY outcome

Timeframe: Baseline and 1-year Follow-up

Average Visual Analog Scale (VAS) pain scores were computed for baseline and 1-year visits for each study arm. This measure is the difference between the average pain score at the baseline and 1-year follow-ups (1-year minus Baseline), stratified by study arm. The scale ranges from 0 to 10, with 0 being "No Pain" and 10 being " Pain as bad as it could possibly be." Lower scores indicate lower levels of reported pain. Negative scores indicate a reduction in pain from baseline to 1-year.

Outcome measures

Measure	Standard Therapy n=19 Participants This arm of the study will follow the standard therapy course after total knee arthroplasty.	Standard Therapy + NMES n=21 Participants This arm will follow the standard course of therapy but also incorporate daily neuromuscular electrical stimulation into the daily therapy regimen after total knee arthroplasty through use of the Compex Rehab device. Compex Rehab: Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment ("Warm-up", "Work", "Relaxation", and "Recovery") for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated.
Change in VAS Pain Scores	-1.06 score on a scale Interval -1.89 to -0.56	-1.07 score on a scale Interval -1.64 to -0.056

Adverse Events

Standard Therapy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard Therapy + NMES

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard Therapy n=19 participants at risk This arm of the study will follow the standard therapy course after total knee arthroplasty.	Standard Therapy + NMES n=21 participants at risk This arm will follow the standard course of therapy but also incorporate daily neuromuscular electrical stimulation into the daily therapy regimen after total knee arthroplasty through use of the Compex Rehab device. Compex Rehab: Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment ("Warm-up", "Work", "Relaxation", and "Recovery") for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated.
Gastrointestinal disorders Peptic Ulcer	0.00% 0/19 • Each subject was questioned about experiences of adverse events at each appointment after baseline and up until that subject completed their 1-year follow-up appointment. Should adverse event information have been reported after a subject completed their final study visit, but before study closeout, those data would also be included herein.	4.8% 1/21 • Each subject was questioned about experiences of adverse events at each appointment after baseline and up until that subject completed their 1-year follow-up appointment. Should adverse event information have been reported after a subject completed their final study visit, but before study closeout, those data would also be included herein.

Other adverse events

Measure	Standard Therapy n=19 participants at risk This arm of the study will follow the standard therapy course after total knee arthroplasty.	Standard Therapy + NMES n=21 participants at risk This arm will follow the standard course of therapy but also incorporate daily neuromuscular electrical stimulation into the daily therapy regimen after total knee arthroplasty through use of the Compex Rehab device. Compex Rehab: Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment ("Warm-up", "Work", "Relaxation", and "Recovery") for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated.
Surgical and medical procedures Knee Manipulation	5.3% 1/19 • Number of events 1 • Each subject was questioned about experiences of adverse events at each appointment after baseline and up until that subject completed their 1-year follow-up appointment. Should adverse event information have been reported after a subject completed their final study visit, but before study closeout, those data would also be included herein.	0.00% 0/21 • Each subject was questioned about experiences of adverse events at each appointment after baseline and up until that subject completed their 1-year follow-up appointment. Should adverse event information have been reported after a subject completed their final study visit, but before study closeout, those data would also be included herein.
Gastrointestinal disorders Acid Reflux	5.3% 1/19 • Number of events 1 • Each subject was questioned about experiences of adverse events at each appointment after baseline and up until that subject completed their 1-year follow-up appointment. Should adverse event information have been reported after a subject completed their final study visit, but before study closeout, those data would also be included herein.	0.00% 0/21 • Each subject was questioned about experiences of adverse events at each appointment after baseline and up until that subject completed their 1-year follow-up appointment. Should adverse event information have been reported after a subject completed their final study visit, but before study closeout, those data would also be included herein.

Additional Information

Dr. Frank Kolisek

OrthoIndy

Phone: 3178845160

Email: fkolisek@orthoindy.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place