Knee Osteoarthritis
Conditions
Brief summary
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.
Interventions
DEVICEBreg Flex
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.
Sponsors
BREG, Inc
The Hawkins Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Individuals who are scheduled for Total Knee Arthroplasty by a single surgeon (Burnikel) 2. Individuals who are at least 55 years of age 3. Individuals with a body mass index (BMI) \<45 4. Must be able and willing to complete all study assessments and to be followed for the full course of the study. 5. Must be able to read, write and follow instructions in English. 6. Must be able and willing to provide informed consent. 7. Must be willing and able to attend the pre-op assessment
Exclusion criteria
1. Individuals with a history of any underlying neurological conditions 2. Individuals with a history of stroke 3. Individuals with a history of neurological disorder that affects lower extremity function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis, etc.) 4. Individuals with physical conditions which would make them unable to perform study procedures 5. Pregnant women or inadequate precautions to prevent pregnancy 6. Diagnosis of a medical condition that would contraindicate treatment with the product, e.g. skin lesions at electrode site. 7. Individuals with a diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout or psoriatic arthritis)? 8. Individuals with muscle diseases (i.e. muscular dystrophy) 9. Visible skin injury or disease on their legs 10. Principal investigator for this study, or member of study staff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Acceptable Symptoms State (PASS) | 52 weeks post op | Patient reported outcome recording patient satisfaction with level of recovery. Patients report that they are either satisfied or not. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Osteoarthritis Outcome Score-JR (KOOS-JR) | 6 week and 1 week preoperatively and 3 ,6, 12, 52 week post op | 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. |
| Number of Participant Physical Therapy Visits | 3 ,6, 12, 52 week post op | The number of Physical therapy visits between data collection time points |
| Range of motion | 6 week and 1 week preoperatively and 3 ,6, 12 week post op | Passive flexion and extension range of motion of knee |
| Strength | 6 week and 1 week preoperatively and 3 ,6, 12 week post op | Strength of quadriceps as measured on Biodex |
Countries
United States
Outcome results
None listed