Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomised Controlled Study To Compare the Effects of a Standard Therapy Protocol With a 12-week Peri-Operative Program of Kneehab XP Compared to a Control Treatment in Patients Undergoing Total Knee Replacement

Conditions
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Total Knee Replacement

Intervention / Treatment
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* Device: Kneehab XP
* Device: Quadriceps TENS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: quadriceps NMES using Kneehab XP<br>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 | Device: Kneehab XP<br>* 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<br>|
| Sham Comparator: quadriceps TENS<br>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 | Device: Quadriceps TENS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | measured at the 6 week post-operative time point | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TKA, NMES, Muscle, strength, Focus to show shorter muscle recovery after Knee operation