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| Name | Class |
|---|---|
| BREG, Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadriceps NMES using Breg Flex | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breg Flex | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATI Physical Therapy | Greenville | South Carolina | 29615 | United States | ||
| Steadman Hawkins Clinic of the Carolinas - Greenville Health System |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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 |
| Greenville |
| South Carolina |
| 29615 |
| United States |
| D012216 |
| Rheumatic Diseases |