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

The Hawkins Foundation

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Device: Breg Flex

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03840096

Pro00075229

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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