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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breg Flex
Sponsored by
The Hawkins Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ATI Physical Therapy
  • Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Quadriceps NMES using Breg Flex

Control

Arm Description

Outcomes

Primary Outcome Measures

Patient Acceptable Symptoms State (PASS)
Patient reported outcome recording patient satisfaction with level of recovery. Patients report that they are either satisfied or not.

Secondary Outcome Measures

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.
Number of Participant Physical Therapy Visits
The number of Physical therapy visits between data collection time points
Range of motion
Passive flexion and extension range of motion of knee
Strength
Strength of quadriceps as measured on Biodex

Full Information

First Posted
February 11, 2019
Last Updated
September 8, 2021
Sponsor
The Hawkins Foundation
Collaborators
BREG, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03840096
Brief Title
Effectiveness of BREG Flex in 12-week Peri-operative Total Knee Arthroplasty
Official Title
Effect of Augmenting a Standard Total Knee Pathway Protocol With a 12-week Peri-Operative Program of BREG Flex
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hawkins Foundation
Collaborators
BREG, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadriceps NMES using Breg Flex
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Breg Flex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Acceptable Symptoms State (PASS)
Description
Patient reported outcome recording patient satisfaction with level of recovery. Patients report that they are either satisfied or not.
Time Frame
52 weeks post op
Secondary Outcome Measure Information:
Title
Knee Osteoarthritis Outcome Score-JR (KOOS-JR)
Description
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.
Time Frame
6 week and 1 week preoperatively and 3 ,6, 12, 52 week post op
Title
Number of Participant Physical Therapy Visits
Description
The number of Physical therapy visits between data collection time points
Time Frame
3 ,6, 12, 52 week post op
Title
Range of motion
Description
Passive flexion and extension range of motion of knee
Time Frame
6 week and 1 week preoperatively and 3 ,6, 12 week post op
Title
Strength
Description
Strength of quadriceps as measured on Biodex
Time Frame
6 week and 1 week preoperatively and 3 ,6, 12 week post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
ATI Physical Therapy
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States

12. IPD Sharing Statement

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

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