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

NCT ID: NCT03840096

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2021-06-15

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Quadriceps NMES using Breg Flex

Group Type: EXPERIMENTAL

Breg Flex

Intervention Type: 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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BREG, Inc

INDUSTRY

Sponsor Role: collaborator

The Hawkins Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ATI Physical Therapy

Greenville, South Carolina, United States

Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

Pro00075229

Identifier Type: -

Identifier Source: org_study_id