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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: Breg Flex

• Registration Number: NCT03840096
• Lead Sponsor: The Hawkins Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadriceps NMES using Breg Flex	Breg Flex	-

Primary Outcome Measures

Name	Time	Method
Patient Acceptable Symptoms State (PASS)	52 weeks post op	Patient reported outcome recording patient satisfaction with level of recovery. Patients report that they are either satisfied or not.

Secondary Outcome Measures

Name	Time	Method
Range of motion	6 week and 1 week preoperatively and 3 ,6, 12 week post op	Passive flexion and extension range of motion of knee
Knee Osteoarthritis Outcome Score-JR (KOOS-JR)	6 week and 1 week preoperatively and 3 ,6, 12, 52 week post op	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	3 ,6, 12, 52 week post op	The number of Physical therapy visits between data collection time points
Strength	6 week and 1 week preoperatively and 3 ,6, 12 week post op	Strength of quadriceps as measured on Biodex

Trial Locations

Locations (2)

Steadman Hawkins Clinic of the Carolinas - Greenville Health System; 🇺🇸 Greenville, South Carolina, United States

ATI Physical Therapy; 🇺🇸 Greenville, South Carolina, United States