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Completed

NCT Number: NCT03840096

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ATI Physical Therapy, Greenville, South Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breg Flex

Device

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 outcomes

  1. 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

  1. Knee Osteoarthritis Outcome Score-JR (KOOS-JR)

    Time frame: 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.

  2. Number of Participant Physical Therapy Visits

    Time frame: 3 ,6, 12, 52 week post op

    The number of Physical therapy visits between data collection time points

  3. Range of motion

    Time frame: 6 week and 1 week preoperatively and 3 ,6, 12 week post op

    Passive flexion and extension range of motion of knee

  4. Strength

    Time frame: 6 week and 1 week preoperatively and 3 ,6, 12 week post op

    Strength of quadriceps as measured on Biodex

Sponsors and collaborators

Lead sponsor

The Hawkins Foundation

Other

Collaborators

  • BREG, Inc

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2019
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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