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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02623660
• Other study ID #: BRC-001
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 1, 2015
• Last updated: January 8, 2016
• Start date: January 2016
• Est. completion date: October 2016

Study information

• Verified date: January 2016
• Source: Bioelectric Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Osteoarthritis of Knee
• Osteoarthritis, Knee
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Centennial Hills Hospital	Las Vegas	Nevada
United States	Nevada Orthopedic and Spine Center	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Bioelectric Research Corporation

Country where clinical trial is conducted

United States, 

References & Publications (10)

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Lin F, Baldessari F, Gyenge CC, Sato T, Chambers RD, Santiago JG, Butcher EC. Lymphocyte electrotaxis in vitro and in vivo. J Immunol. 2008 Aug 15;181(4):2465-71. — View Citation

Man IO, Markland KL, Morrissey MC. The validity and reliability of the Perometer in evaluating human knee volume. Clin Physiol Funct Imaging. 2004 Nov;24(6):352-8. — View Citation

McCaig CD, Rajnicek AM, Song B, Zhao M. Controlling cell behavior electrically: current views and future potential. Physiol Rev. 2005 Jul;85(3):943-78. Review. — View Citation

Pichonnaz C, Bassin JP, Currat D, Martin E, Jolles BM. Bioimpedance for oedema evaluation after total knee arthroplasty. Physiother Res Int. 2013 Sep;18(3):140-7. doi: 10.1002/pri.1540. Epub 2012 Nov 27. — View Citation

Sato MJ, Kuwayama H, van Egmond WN, Takayama AL, Takagi H, van Haastert PJ, Yanagida T, Ueda M. Switching direction in electric-signal-induced cell migration by cyclic guanosine monophosphate and phosphatidylinositol signaling. Proc Natl Acad Sci U S A. 2009 Apr 21;106(16):6667-72. doi: 10.1073/pnas.0809974106. Epub 2009 Apr 3. — View Citation

Shi R, Borgens RB. Three-dimensional gradients of voltage during development of the nervous system as invisible coordinates for the establishment of embryonic pattern. Dev Dyn. 1995 Feb;202(2):101-14. — View Citation

Soong HK, Parkinson WC, Bafna S, Sulik GL, Huang SC. Movements of cultured corneal epithelial cells and stromal fibroblasts in electric fields. Invest Ophthalmol Vis Sci. 1990 Nov;31(11):2278-82. — View Citation

Zhao M, Dick A, Forrester JV, McCaig CD. Electric field-directed cell motility involves up-regulated expression and asymmetric redistribution of the epidermal growth factor receptors and is enhanced by fibronectin and laminin. Mol Biol Cell. 1999 Apr;10(4):1259-76. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	120 days	No
Primary	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.	120 Days	No
Secondary	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.	90 days	No
Secondary	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.	60 Days	No
Secondary	Increased healing of the surgical incision	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	No
Secondary	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.	90 days	No

External Links

•   Joint Implant Surgery & Research Foundation