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

NCT03840096 | Completed FDA Device

• 1 other identifier: Pro00075229
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Knee Osteoarthritis Outcome Score-JR (KOOS-JR)

  6 week and 1 week preoperatively and 3 ,6, 12, 52 week post op

• Number of Participant Physical Therapy Visits

  3 ,6, 12, 52 week post op

• Range of motion

  6 week and 1 week preoperatively and 3 ,6, 12 week post op

• Strength

  6 week and 1 week preoperatively and 3 ,6, 12 week post op

Study Arms (2)

Quadriceps NMES using Breg Flex

EXPERIMENTAL

Device: Breg Flex

Control

NO INTERVENTION

Interventions

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.

Quadriceps NMES using Breg Flex

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hawkins Foundation: lead
• BREG, Inc: collaborator

Study Sites (2)

ATI Physical Therapy

Greenville, South Carolina, 29615, United States

Location

Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: June 1, 2018
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

US (2)