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

Primary Purpose

Osteoarthritis of Knee, Edema, Wounds and Injuries

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ODIN1

Standard Care

Diagnostic Device Testing

About this trial

This is an interventional treatment trial for Osteoarthritis of Knee focused on measuring Inflammation, Edema, Arthroplasty, Rehabilitation, Replacement, Knee, Total Knee Replacement, Pain, Postoperative, Exercise Therapy, Therapeutics, Early Ambulation, Myofunctional Therapy, Electric Stimulation Therapy, Orthopedic Procedures, Wound Healing, Total Knee Arthroplasty

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Subject younger than 18 years of age
Any patient with an electrically implanted device such as a pacemaker, neural stimulator, etc.
Subject has any known neoplasms
A demonstrated lack of compliance as determined by the Principal Investigator, nurse, or wound care specialist
Current participation in another clinical study of an investigational device or drug.
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
Subject unwilling or unable to provide informed consent
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.
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
Subjects with significant peripheral extremity lymph edema
Subjects with Stage III or IV peripheral vascular disease, as defined by the Fontaine stages
Subjects with venous insufficiencies of Class III or greater, as defined by the Comprehensive Classification System for Chronic Venous Disorders (CEAP)
Subjects with muscle skeletal disorders that are not related to the knee
Subjects with uncontrolled Blood Pressure
Subjects with neurological disease affecting locomotion
Subjects with BMI > 35
Subjects that are active smokers
Subjects that live on the second floor or higher without elevator access
Subjects must not have had a prior TKA. This study is for Primary TKA patients

Sites / Locations

Nevada Orthopedic and Spine Center
Centennial Hills Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

This group will receive treatment from the ODIN1 device in conjunction with standard care and diagnostic device testing.

This group will receive the standard care and the diagnostic device testing.

Outcomes

Primary Outcome Measures

Rate of Reduction of post-operative edema

Determine the rate of reduction in edema by measuring the volume changes in the operated lower extremity over time

Decrease in time to heal

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.

Secondary Outcome Measures

Reduction of pain

Record the degree of pain experienced by measuring the pain level on the universal pain scale of 1-10 over time elapsed since surgery.

Reduction of bacterial infections

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.

Increased healing of the surgical incision

Photograph and rate incision healing from 1st post-op day through day 60 comparing all participants.

Reduction of Pain Medication Usage

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.

Full Information

NCT ID

NCT02623660

First Posted

December 1, 2015

Last Updated

January 8, 2016

Sponsor

Bioelectric Research Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02623660

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioelectric Research Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of Knee, Edema, Wounds and Injuries

Keywords

Inflammation, Edema, Arthroplasty, Rehabilitation, Replacement, Knee, Total Knee Replacement, Pain, Postoperative, Exercise Therapy, Therapeutics, Early Ambulation, Myofunctional Therapy, Electric Stimulation Therapy, Orthopedic Procedures, Wound Healing, Total Knee Arthroplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

This group will receive treatment from the ODIN1 device in conjunction with standard care and diagnostic device testing.

Arm Title

Control

Arm Type

Active Comparator

Arm Description

This group will receive the standard care and the diagnostic device testing.

Intervention Type

Device

Intervention Name(s)

ODIN1

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard Care

Intervention Description

Anti-thrombotic medication. Elevation and ice. Pain medications as needed. Dressings changes. Topical antibiotics. Progressive physical therapy.

Intervention Type

Device

Intervention Name(s)

Diagnostic Device Testing

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of Reduction of post-operative edema

Description

Determine the rate of reduction in edema by measuring the volume changes in the operated lower extremity over time

Time Frame

120 days

Title

Decrease in time to heal

Description

Time Frame

120 Days

Secondary Outcome Measure Information:

Title

Reduction of pain

Description

Record the degree of pain experienced by measuring the pain level on the universal pain scale of 1-10 over time elapsed since surgery.

Time Frame

90 days

Title

Reduction of bacterial infections

Description

Time Frame

60 Days

Title

Increased healing of the surgical incision

Description

Photograph and rate incision healing from 1st post-op day through day 60 comparing all participants.

Time Frame

From the 1st post-op day until 60 Days post-op

Title

Reduction of Pain Medication Usage

Description

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.

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be scheduled for a primary total knee replacement surgery Age: 18 - 80 years old Males/Females all ethnicities Must have a minimum serum albumin of 4 and a minimum Hgb of 11 Ability to mark appropriately the visual analog scales, keep a log of symptoms, medication use, and ODIN1® use Ability to understand all instructions and the informed consent document before signing it Exclusion Criteria: Subject younger than 18 years of age Any patient with an electrically implanted device such as a pacemaker, neural stimulator, etc. Subject has any known neoplasms A demonstrated lack of compliance as determined by the Principal Investigator, nurse, or wound care specialist Current participation in another clinical study of an investigational device or drug. 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 Subject unwilling or unable to provide informed consent 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. 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 Subjects with significant peripheral extremity lymph edema Subjects with Stage III or IV peripheral vascular disease, as defined by the Fontaine stages Subjects with venous insufficiencies of Class III or greater, as defined by the Comprehensive Classification System for Chronic Venous Disorders (CEAP) Subjects with muscle skeletal disorders that are not related to the knee Subjects with uncontrolled Blood Pressure Subjects with neurological disease affecting locomotion Subjects with BMI > 35 Subjects that are active smokers Subjects that live on the second floor or higher without elevator access Subjects must not have had a prior TKA. This study is for Primary TKA patients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ron Hillock, M.D.

Organizational Affiliation

Centennial Hills Hospital & University of Nevada School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nevada Orthopedic and Spine Center

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Centennial Hills Hospital

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89149

Country

United States

12. IPD Sharing Statement

Citations:

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7734729

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Links:

URL

http://www.jisrf.org

Description

Joint Implant Surgery & Research Foundation

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

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