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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
ATI Physical Therapy
Greenville, South Carolina, United States
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Greenville, South Carolina, United States
Patient Acceptable Symptoms State (PASS)
Patient reported outcome recording patient satisfaction with level of recovery. Patients report that they are either satisfied or not.
Time frame: 52 weeks post op
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.
Time frame: 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
Time frame: 3 ,6, 12, 52 week post op
Range of motion
Passive flexion and extension range of motion of knee
Time frame: 6 week and 1 week preoperatively and 3 ,6, 12 week post op
Strength
Strength of quadriceps as measured on Biodex
Time frame: 6 week and 1 week preoperatively and 3 ,6, 12 week post op
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