Trials / Completed
CompletedNCT03840096
Effectiveness of BREG Flex in 12-week Peri-operative Total Knee Arthroplasty
Effect of Augmenting a Standard Total Knee Pathway Protocol With a 12-week Peri-Operative Program of BREG Flex
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- The Hawkins Foundation · Academic / Other
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Breg 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. |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2021-06-15
- Completion
- 2021-06-15
- First posted
- 2019-02-15
- Last updated
- 2021-09-09
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03840096. Inclusion in this directory is not an endorsement.