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

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.

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