Total Knee Replacement
Conditions
Keywords
NMES, Muscle, strength, TKA, Focus to show shorter muscle recovery after Knee operation
Brief summary
The study is a prospective, randomized, double-blind sham study of TKA patients who receive a standard peri-operative treatment program plus Kneehab XP versus a standard peri-operative treatment program plus a sham device.
Detailed description
The study is a double-blind randomized controlled clinical trial of approximately 118 patients (males and females) who are at least 40 years of age, who are scheduled for Total Knee Arthroplasty (TKA) surgery will be randomized into 1) a treatment group who receive Kneehab XP and a standard rehabilitation program and 2) a control group who receive only a sham device and a standard rehabilitation program. Patients are tracked for measures of function, pain, quality of life, physical performance and acceptable states status at 6 weeks and 1 week before surgery and 3, 6, 12, and 52 weeks following surgery.
Interventions
DEVICEKneehab 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
DEVICEQuadriceps TENS
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.
Sponsors
Theragen Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals who are scheduled for Total Knee Replacement surgery with the Smith and Nephew Visionaire prosthesis and the anterior surgical approach. * Individuals who are at least 40 years of age. * Individuals with a body mass index (BMI) \<40 kg/ m2 * Individuals who are walking independently with or without assistive devices. * Individuals with a Short Performance Battery Score greater than 7. * Must be able and willing to complete all study assessments and to be followed for the full course of the study. * Must be able to read, write and follow instructions in English. * Must be able and willing to provide informed consent. * Must be willing and able to attend the additional pre-operative assessment.
Exclusion criteria
* Individuals with a history of foot and/or ankle pathology. * Individuals with a history of tibial or femoral fractures. * Individuals with a history of any underlying neurological conditions. * Individuals with physical conditions which would make them unable to perform study procedures. * Individuals with a total hip replacement. * Individuals undergoing revision TKA of the same operated leg. * Individuals who are pregnant. * Individuals diagnosed with a medical condition that would contraindicate treatment with the product, e.g. skin lesions at electrode site. * Individuals with an active implanted medical device (i.e. pacemaker, pump) * Individuals with a history of stroke * Individuals with a history of neurological disorder that affects lower extremity function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis, etc.) * Individuals with a diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout or psoriatic arthritis). * Individuals with muscle diseases (i.e. muscular dystrophy) * Individuals with visible skin injury or disease on their legs. * Individuals who have been committed to an institution by virtue of an order issued either by the courts or by an authority.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Isometric Strength Test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Positive PASS | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | 1 wk pre-operatively, 3,6,12,52 week post operatively | Change in scores of functional and physical performance scores |
| Timed to Get up and go | 1 wk pre-operatively, 3,6,12,52 week post operatively | Change in scores of physical performance measures |
| Physical Therapy Sessions | 1 wk pre-operatively, 3,6,12,52 week post operatively | Change in patient functional measures and number of therapy sessions required. |
| Visual Analogue Scales (VAS) | 1 wk pre-operatively,3,6,12 and 52 post operatively | Pain change score in VAS from baseline to week 6 post-surgery |
| Stair Climb Test | 1 wk pre-operatively, 3,6,12,52 week post operatively | Change in scores of physical performance measures |
| Questionnaires | 1 wk pre-operatively, 3,6,12,52 week post operatively | Change in scores in patient outcome measures, functional measures and physical performance measures |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 56 |
| 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. | 55 |
| Total | 111 |
Baseline characteristics
| Characteristic | Total | Quadriceps NMES Using Kneehab XP | Quadriceps TENS |
|---|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 9.24 | 65.1 years STANDARD_DEVIATION 8.23 | 64.5 years STANDARD_DEVIATION 10.23 |
| Body Mass Index (BMI) | 29.7 Kg/m^2 STANDARD_DEVIATION 5.11 | 30.0 Kg/m^2 STANDARD_DEVIATION 5.03 | 29.4 Kg/m^2 STANDARD_DEVIATION 5.23 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United States | 111 participants | 56 participants | 55 participants |
| Sex: Female, Male Female | 64 Participants | 32 Participants | 32 Participants |
| Sex: Female, Male Male | 47 Participants | 24 Participants | 23 Participants |
| Smoking Status Current | 4 Participants | 3 Participants | 1 Participants |
| Smoking Status Ex | 37 Participants | 17 Participants | 20 Participants |
| Smoking Status Non | 70 Participants | 36 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 55 |
| other Total, other adverse events | 7 / 56 | 0 / 55 |
| serious Total, serious adverse events | 0 / 56 | 0 / 55 |
Outcome results
Primary
Isometric Strength Test
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.
Time frame: measured at the 6 week post-operative time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quadriceps NMES Using Kneehab XP | Isometric Strength Test | -21.9 Newton-metres | Standard Deviation 21.74 |
| Quadriceps TENS | Isometric Strength Test | -31.9 Newton-metres | Standard Deviation 28.43 |
Secondary
Percentage of Patients With Positive PASS
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
Time frame: measured at the 6 week post-operative time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quadriceps NMES Using Kneehab XP | Percentage of Patients With Positive PASS | Baseline | 25.0 % of participants |
| Quadriceps NMES Using Kneehab XP | Percentage of Patients With Positive PASS | 6 week post-surgery | 73.5 % of participants |
| Quadriceps TENS | Percentage of Patients With Positive PASS | Baseline | 16.4 % of participants |
| Quadriceps TENS | Percentage of Patients With Positive PASS | 6 week post-surgery | 61.2 % of participants |
Other Pre-specified
Physical Therapy Sessions
Change in patient functional measures and number of therapy sessions required.
Time frame: 1 wk pre-operatively, 3,6,12,52 week post operatively
Other Pre-specified
Questionnaires
Change in scores in patient outcome measures, functional measures and physical performance measures
Time frame: 1 wk pre-operatively, 3,6,12,52 week post operatively
Other Pre-specified
Range of Motion
Change in scores of functional and physical performance scores
Time frame: 1 wk pre-operatively, 3,6,12,52 week post operatively
Other Pre-specified
Stair Climb Test
Change in scores of physical performance measures
Time frame: 1 wk pre-operatively, 3,6,12,52 week post operatively
Other Pre-specified
Timed to Get up and go
Change in scores of physical performance measures
Time frame: 1 wk pre-operatively, 3,6,12,52 week post operatively
Other Pre-specified
Visual Analogue Scales (VAS)
Pain change score in VAS from baseline to week 6 post-surgery
Time frame: 1 wk pre-operatively,3,6,12 and 52 post operatively