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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| quadriceps NMES using Kneehab XP | Experimental | All subjects in the treatment group will receive quadriceps Neuro Muscular Electrical Stimulation (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 |
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| quadriceps TENS | Sham Comparator | The sham device will look identical to the Kneehab XP device. All subjects in the control group will receive quadriceps Transcutaneous Electrical Nerve Stimulation (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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kneehab XP | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | measured at the 6 week post-operative time point |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Therapy Sessions | Change in patient functional measures and number of therapy sessions required. | 1 wk pre-operatively, 3,6,12,52 week post operatively |
| Questionnaires | Change in scores in patient outcome measures, functional measures and physical performance measures |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Burnikel | Hawkins Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawkins Foundation | Greenville | South Carolina | 29615 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Newton-metres | measured at the 6 week post-operative time point |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Pearce | Theragen Inc. | 901 634 0544 | richard.pearce@theragen.com |
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| Quadriceps TENS | Device | 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. |
|
| measured at the 6 week post-operative time point |
| 1 wk pre-operatively, 3,6,12,52 week post operatively |
| Range of Motion | Change in scores of functional and physical performance scores | 1 wk pre-operatively, 3,6,12,52 week post operatively |
| Timed to Get up and go | Change in scores of physical performance measures | 1 wk pre-operatively, 3,6,12,52 week post operatively |
| Stair Climb Test | Change in scores of physical performance measures | 1 wk pre-operatively, 3,6,12,52 week post operatively |
| Visual Analogue Scales (VAS) | Pain change score in VAS from baseline to week 6 post-surgery | 1 wk pre-operatively,3,6,12 and 52 post operatively |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking Status | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m^2 |
|
| OG001 | 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. |
|
|
| 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 | Posted | Number | % of participants | measured at the 6 week post-operative time point |
|
|
|
| Other Pre-specified | Physical Therapy Sessions | Change in patient functional measures and number of therapy sessions required. | Not Posted | 1 wk pre-operatively, 3,6,12,52 week post operatively | Participants |
| Other Pre-specified | Questionnaires | Change in scores in patient outcome measures, functional measures and physical performance measures | Not Posted | 1 wk pre-operatively, 3,6,12,52 week post operatively | Participants |
| Other Pre-specified | Range of Motion | Change in scores of functional and physical performance scores | Not Posted | 1 wk pre-operatively, 3,6,12,52 week post operatively | Participants |
| Other Pre-specified | Timed to Get up and go | Change in scores of physical performance measures | Not Posted | 1 wk pre-operatively, 3,6,12,52 week post operatively | Participants |
| Other Pre-specified | Stair Climb Test | Change in scores of physical performance measures | Not Posted | 1 wk pre-operatively, 3,6,12,52 week post operatively | Participants |
| Other Pre-specified | Visual Analogue Scales (VAS) | Pain change score in VAS from baseline to week 6 post-surgery | Not Posted | 1 wk pre-operatively,3,6,12 and 52 post operatively | Participants |
| 0 |
| 56 |
| 0 |
| 56 |
| 7 |
| 56 |
| EG001 | 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. | 0 | 55 | 0 | 55 | 0 | 55 |
| Pain | General disorders | Systematic Assessment | Mild pain associated with device |
|
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| Ex |
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