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

Knee Osteoarthritis Clinical Trial

Official title:

Effect of Augmenting a Standard Total Knee Pathway Protocol With a 12-week Peri-Operative Program of BREG Flex

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03840096
• Other study ID #: Pro00075229
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 15, 2021

Study information

• Verified date: September 2021
• Source: The Hawkins Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	ATI Physical Therapy	Greenville	South Carolina
United States	Steadman Hawkins Clinic of the Carolinas - Greenville Health System	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
The Hawkins Foundation	BREG, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Participant Physical Therapy Visits	The number of Physical therapy visits between data collection time points	3 ,6, 12, 52 week post op
Secondary	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
Secondary	Strength	Strength of quadriceps as measured on Biodex	6 week and 1 week preoperatively and 3 ,6, 12 week post op