Trial Outcomes & Findings for Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement (NCT NCT01548040)

Results Overview

To determine the efficacy of Kneehab XP in promoting early quadriceps strength improvement (measured as the difference between the baseline time point and the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty. Isometric strength was measured using a Biodex Isokinetic Dynamometer machine on patients seated and secured to a chair and who performed 3 maximal voluntary contractions (MVC) for which the maximal torque is measured and a mean taken of 3 consecutive MVC's.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

111 participants

Primary outcome timeframe

measured at the 6 week post-operative time point

Results posted on

2018-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Quadriceps NMES Using Kneehab XP All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively	Quadriceps TENS The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.
Overall Study STARTED	56	55
Overall Study COMPLETED	43	45
Overall Study NOT COMPLETED	13	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quadriceps NMES Using Kneehab XP n=56 Participants All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively	Quadriceps TENS n=55 Participants The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.	Total n=111 Participants Total of all reporting groups
Body Mass Index (BMI)	30.0 Kg/m^2 STANDARD_DEVIATION 5.03 • n=56 Participants	29.4 Kg/m^2 STANDARD_DEVIATION 5.23 • n=55 Participants	29.7 Kg/m^2 STANDARD_DEVIATION 5.11 • n=111 Participants
Age, Continuous	65.1 years STANDARD_DEVIATION 8.23 • n=56 Participants	64.5 years STANDARD_DEVIATION 10.23 • n=55 Participants	64.8 years STANDARD_DEVIATION 9.24 • n=111 Participants
Sex: Female, Male Female	32 Participants n=56 Participants	32 Participants n=55 Participants	64 Participants n=111 Participants
Sex: Female, Male Male	24 Participants n=56 Participants	23 Participants n=55 Participants	47 Participants n=111 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	56 participants n=56 Participants	55 participants n=55 Participants	111 participants n=111 Participants
Smoking Status Current	3 Participants n=56 Participants	1 Participants n=55 Participants	4 Participants n=111 Participants
Smoking Status Non	36 Participants n=56 Participants	34 Participants n=55 Participants	70 Participants n=111 Participants
Smoking Status Ex	17 Participants n=56 Participants	20 Participants n=55 Participants	37 Participants n=111 Participants

PRIMARY outcome

Timeframe: measured at the 6 week post-operative time point

To determine the efficacy of Kneehab XP in promoting early quadriceps strength improvement (measured as the difference between the baseline time point and the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty. Isometric strength was measured using a Biodex Isokinetic Dynamometer machine on patients seated and secured to a chair and who performed 3 maximal voluntary contractions (MVC) for which the maximal torque is measured and a mean taken of 3 consecutive MVC's.

Outcome measures

Outcome measures
Measure	Quadriceps NMES Using Kneehab XP n=56 Participants All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively	Quadriceps TENS n=55 Participants The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.
Isometric Strength Test	-21.9 Newton-metres Standard Deviation 21.74	-31.9 Newton-metres Standard Deviation 28.43

SECONDARY outcome

Timeframe: measured at the 6 week post-operative time point

To determine whether Kneehab XP leads to earlier recovery (measured at the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty. Patient Acceptable Symptom State (PASS) is a yes/no answer to a specifically stated question about the patients satisfaction with their state. For clarity, Positive PASS implies that the answer that is given is Positive i.e. Yes

Outcome measures

Outcome measures
Measure	Quadriceps NMES Using Kneehab XP n=56 Participants All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively	Quadriceps TENS n=55 Participants The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.
Percentage of Patients With Positive PASS Baseline	25.0 % of participants	16.4 % of participants
Percentage of Patients With Positive PASS 6 week post-surgery	73.5 % of participants	61.2 % of participants

Adverse Events

Quadriceps NMES Using Kneehab XP

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Quadriceps TENS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Quadriceps NMES Using Kneehab XP n=56 participants at risk All subjects in the treatment group will receive quadriceps NMES using Kneehab XP on the affected leg, 20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation Kneehab XP: NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively	Quadriceps TENS n=55 participants at risk The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps TENS (at a minimal sensory input) using Kneehab XP on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.group will also complete the standard TKA post-surgery rehabilitation program used at the Hawkins Foundation quadriceps TENS (at a minimal sensory input) using Kneehab XP: on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.
Injury, poisoning and procedural complications Fall	5.4% 3/56 • Number of events 3	0.00% 0/55
General disorders Pain	7.1% 4/56 • Number of events 4	0.00% 0/55

Additional Information

Richard Pearce

Theragen Inc.

Phone: 901 634 0544

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place