Microcurrent Stimulation Reduces Post-Operative Swelling and Healing Time Following Knee Replacement Surgery

January 8, 2016 updated by: Bioelectric Research Corporation

Accelerated Reduction of Post-operative Edema and Early Return to Function Following Total Knee Arthroplasty (TKA)

The purpose of this study is to determine if patients undergoing a total knee arthroplasty (TKA) experience a clinically significant reduction in healing time when treated post operatively with a specific form of micro and nano-ampere current. The results of this trial will provide a basis for generalizing its outcomes to apply to other joint replacements and revisions by reducing edema and inflammation and therefore will result in a shorter time to heal.

The study will compare electrically treated and non electrically treated patients by using digitally based measurements to determine objective reductions of lower extremity edema including intra and inter cellular shifts in fluid distribution, increased range of motion (ROM) and muscle strength, and improved functional tests of ambulation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is intended to assess the efficiency and efficacy of the ODIN1® microcurrent generating device to reduce post-operative edema, shorten the time to heal and regain maximum function in total knee replacement patients. Changes in swelling will be documented by utilizing a 3D scanning device (Perometer) and a Bio-Impedance Spectroscopy (BIS) device (Impedimed SFB7). These instruments quantitate limb volume and inter and intra-cellular fluid respectively with a high degree of accuracy. Measurements will be made from the first post-operative day until the completion of rehabilitation therapy several months later.

Edema volume and fluid distribution data collected from both control and experimental groups will be compared to determine the statistical significance of the difference between these groups. An additional analysis will be performed on data collected from the non-operated lower limb of each patient.

The second primary objective is to determine the time to complete post-op rehabilitation. Completion will be determined by the ability of the patient to experience an optimal outcome by utilizing performance based measurements of knee function including quadriceps strength and range of motion. The time from surgery to optimal post-op rehabilitation will be recorded.

The determinations of statistical significance between the electrically treated and non-electrically treated groups will be made by analysts on a blind basis. They will not know whether a sample data set is from an experimental or control patient. The codes that document which group the set belongs to will be opened after all analysis is completed by an independent analyst.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Nevada Orthopedic and Spine Center
      • Las Vegas, Nevada, United States, 89149
        • Centennial Hills Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients must be scheduled for a primary total knee replacement surgery
  2. Age: 18 - 80 years old
  3. Males/Females all ethnicities
  4. Must have a minimum serum albumin of 4 and a minimum Hgb of 11
  5. Ability to mark appropriately the visual analog scales, keep a log of symptoms, medication use, and ODIN1® use
  6. Ability to understand all instructions and the informed consent document before signing it

Exclusion Criteria:

  1. Subject younger than 18 years of age
  2. Any patient with an electrically implanted device such as a pacemaker, neural stimulator, etc.
  3. Subject has any known neoplasms
  4. A demonstrated lack of compliance as determined by the Principal Investigator, nurse, or wound care specialist
  5. Current participation in another clinical study of an investigational device or drug.
  6. Any other condition or finding, which in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the protocol
  7. Subject unwilling or unable to provide informed consent
  8. Subjects receiving any medication or having any condition that significantly interferes with the healing process such as a patient taking systemic steroids or immune suppressants or patient has diabetes mellitus with an HbA1c of greater than 7.5, etc.
  9. Any female who has experienced menstruation and is less than 5 years postmenopausal shall have a urine pregnancy test before the initial treatment. An additional test will be performed at 3 weeks from the initial treatment date. Any subject with a positive pregnancy test shall be excluded
  10. Subjects with significant peripheral extremity lymph edema
  11. Subjects with Stage III or IV peripheral vascular disease, as defined by the Fontaine stages
  12. Subjects with venous insufficiencies of Class III or greater, as defined by the Comprehensive Classification System for Chronic Venous Disorders (CEAP)
  13. Subjects with muscle skeletal disorders that are not related to the knee
  14. Subjects with uncontrolled Blood Pressure
  15. Subjects with neurological disease affecting locomotion
  16. Subjects with BMI > 35
  17. Subjects that are active smokers
  18. Subjects that live on the second floor or higher without elevator access
  19. Subjects must not have had a prior TKA. This study is for Primary TKA patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
This group will receive treatment from the ODIN1 device in conjunction with standard care and diagnostic device testing.
Device: ODIN1

Shortly after surgery, electrodes will be applied to the lower extremity in such a way that the current will flow from the ankle through the knee replacement and pass through the thigh. The frequency of the treatments will vary over the period of time from post-op recovery to end of rehab.

All treatments are applying current that consists of different combinations of intensities within the micro to nano ampere ranges.

Other: Standard Care
Anti-thrombotic medication. Elevation and ice. Pain medications as needed. Dressings changes. Topical antibiotics. Progressive physical therapy.
Device: Diagnostic Device Testing
Diagnostic interventions include: the Perometer which scans the lower extremity and determines its volume to a high degree of accuracy; the Impedimed Bioimpedance Spectroscopy (BIS) device that measures intra and intercellular fluid movement; the Microfet muscle force testing device that provides a digital output of the number of pounds exerted by the quadriceps upon extension; the Acumar digital digital Inclinometer that accurately measures the ROM of the knee; and the K.I.S.S. wound measuring system to measure rate of incision healing.
Active Comparator: Control
This group will receive the standard care and the diagnostic device testing.
Other: Standard Care
Anti-thrombotic medication. Elevation and ice. Pain medications as needed. Dressings changes. Topical antibiotics. Progressive physical therapy.
Device: Diagnostic Device Testing
Diagnostic interventions include: the Perometer which scans the lower extremity and determines its volume to a high degree of accuracy; the Impedimed Bioimpedance Spectroscopy (BIS) device that measures intra and intercellular fluid movement; the Microfet muscle force testing device that provides a digital output of the number of pounds exerted by the quadriceps upon extension; the Acumar digital digital Inclinometer that accurately measures the ROM of the knee; and the K.I.S.S. wound measuring system to measure rate of incision healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Reduction of post-operative edema
Time Frame: 120 days
Determine the rate of reduction in edema by measuring the volume changes in the operated lower extremity over time
120 days
Decrease in time to heal
Time Frame: 120 Days
Determine the rate of healing by measuring the time elapsed from surgery to reach optimal function by measuring muscle strength, range of knee motion, standardized rehabilitation testing designed to quantitatively measure ambulation. When these measurements show no signs of improvement for a period of 30 days or greater, then the time elapsed after surgery until the beginning of this 30 day or greater period will be recorded and used as a measure of time to heal.
120 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of pain
Time Frame: 90 days
Record the degree of pain experienced by measuring the pain level on the universal pain scale of 1-10 over time elapsed since surgery.
90 days
Reduction of bacterial infections
Time Frame: 60 Days
Compare the incidence of TKA related infections in all participants. The measurement will be the number of recorded infections, related to the surgery, that has occurred within the first 60 days of that surgery in all participants. That number will be compared between the experimental and the control groups.
60 Days
Increased healing of the surgical incision
Time Frame: From the 1st post-op day until 60 Days post-op
Photograph and rate incision healing from 1st post-op day through day 60 comparing all participants.
From the 1st post-op day until 60 Days post-op
Reduction of Pain Medication Usage
Time Frame: 90 days
Record the consumption of all pain medications consumed to mitigate post-operative pain. A total dosage will be calculated in terms of morphine equivalent strengths and compared between the groups.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioelectric Research Corporation

Investigators

  • Principal Investigator: Ron Hillock, M.D., Centennial Hills Hospital & University of Nevada School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 8, 2015

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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