Effectiveness of BREG Flex in 12-week Peri-operative Total Knee Arthroplasty

Study Overview
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Brief Summary
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Patient outcomes following total knee replacement and standard physical therapy will be compared between subjects who use the Breg Flex study device vs those who do not. Subjects will be evaluated for knee range of motion, strength and patient reported outcomes.

Official Title
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Effect of Augmenting a Standard Total Knee Pathway Protocol With a 12-week Peri-Operative Program of BREG Flex

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Breg Flex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who are scheduled for Total Knee Arthroplasty by a single surgeon (Burnikel) Individuals who are at least 55 years of age Individuals with a body mass index (BMI) <45 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 pre-op assessment Exclusion Criteria: Individuals with a history of any underlying neurological conditions 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 physical conditions which would make them unable to perform study procedures Pregnant women or inadequate precautions to prevent pregnancy Diagnosis of a medical condition that would contraindicate treatment with the product, e.g. skin lesions at electrode site. Individuals with a diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout or psoriatic arthritis)? Individuals with muscle diseases (i.e. muscular dystrophy) Visible skin injury or disease on their legs Principal investigator for this study, or member of study staff

Ages Eligible for Study
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Minimum Age: 55 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadriceps NMES using Breg Flex<br> | Device: Breg Flex<br>* All subjects in the treatment group will receive quadriceps Neuro Muscular Electrical Stimulation using Breg Flex device on the affected leg to guide and monitor of knee HEP during the 6 weeks prior to surgery and 12 weeks following surgery.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Acceptable Symptoms State (PASS) | Patient reported outcome recording patient satisfaction with level of recovery. Patients report that they are either satisfied or not. | 52 weeks post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Osteoarthritis Outcome Score-JR (KOOS-JR) | Patient reported outcome measuring knee joint specific pain and physical function. The answer values range from none to extreme to describe pain and physical limitation. | 6 week and 1 week preoperatively and 3 ,6, 12, 52 week post op | 
| Number of Participant Physical Therapy Visits | The number of Physical therapy visits between data collection time points | 3 ,6, 12, 52 week post op | 
| Range of motion | Passive flexion and extension range of motion of knee | 6 week and 1 week preoperatively and 3 ,6, 12 week post op | 
| Strength | Strength of quadriceps as measured on Biodex | 6 week and 1 week preoperatively and 3 ,6, 12 week post op |