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

The Hawkins Foundation2 sites in 1 country200 target enrollmentJune 1, 2018

ConditionsKnee Osteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: The Hawkins Foundation
Enrollment: 200
Locations: 2
Primary Endpoint: Patient Acceptable Symptoms State (PASS)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 1, 2018

End Date

June 15, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Hawkins Foundation

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Patient Acceptable Symptoms State (PASS)

Time Frame: 52 weeks post op

Patient reported outcome recording patient satisfaction with level of recovery. Patients report that they are either satisfied or not.

Secondary Outcomes

Knee Osteoarthritis Outcome Score-JR (KOOS-JR)(6 week and 1 week preoperatively and 3 ,6, 12, 52 week post op)
Range of motion(6 week and 1 week preoperatively and 3 ,6, 12 week post op)
Number of Participant Physical Therapy Visits(3 ,6, 12, 52 week post op)
Strength(6 week and 1 week preoperatively and 3 ,6, 12 week post op)