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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Breg Flex

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Steadman Hawkins Clinic of the Carolinas - Greenville Health System
    • Greenville, South Carolina, United States, 29615
      • ATI Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Quadriceps NMES using Breg Flex	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The Hawkins Foundation
• Collaborators: BREG, Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Pro00075229

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes