Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03840096
NCT03840096CompletedNot Applicable

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 enrollmentStarted: June 1, 2018Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
200
Locations
2
Primary Endpoint
Patient Acceptable Symptoms State (PASS)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
55 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Quadriceps NMES using Breg Flex

Experimental

Intervention: Breg Flex (Device)

Control

No Intervention

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Completed
Not Applicable
The effect of implant design on patient outcomes following total knee replacementOsteoarthritis / total knee arthroplastyMusculoskeletal DiseasesGonarthrosis [arthrosis of knee]
ISRCTN85418379niversity of Edinburgh (UK)204
Unknown
Not Applicable
Making Sense Out of Total Knee Sensor Assisted Technology: A Randomized Control TrialArthroplasty, Replacement, Knee
NCT02717299TriHealth Inc.78
Unknown
Not Applicable
Conventional Versus Patient-specific Instruments in Total Knee ArthroplastyOsteoarthritis, Patient-specific Instruments
NCT02993016The Catholic University of Korea100
Recruiting
Not Applicable
Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee ArthroplastyOsteoarthritis Knee RightKnee DiseaseArthropathy of Knee JointOsteoarthritis Knee LeftOsteoarthritis, KneeOsteoarthritis Knees BothKnee Pain ChronicKnee Osteoarthritis
NCT04814082LifeBridge Health100
Recruiting
Not Applicable
A Randomised Control Trial Comparing Functional Outcomes for Navigated Kinematically Aligned TKR Versus Navigated Mechanically Aligned TKRKinematical Alignment,Mechanical Alignment, Navigation
NCT04246138Hull University Teaching Hospitals NHS Trust100