Clinical trial NCT02623660: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Bioelectric Research Corporation
Sponsor class: INDUSTRY
First posted: 2015-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Reduction of post-operative edema
timeFrame: 120 days
measure: Decrease in time to heal
timeFrame: 120 Days
Secondary outcomes:
measure: Reduction of pain
timeFrame: 90 days
measure: Reduction of bacterial infections
timeFrame: 60 Days
measure: Increased healing of the surgical incision
timeFrame: From the 1st post-op day until 60 Days post-op
measure: Reduction of Pain Medication Usage
timeFrame: 90 days
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Nevada Orthopedic and Spine Center
state: Nevada
city: Las Vegas
country: United States
facility: Centennial Hills Hospital
state: Nevada
Study officials:
affiliation: Centennial Hills Hospital & University of Nevada School of Medicine
name: Ron Hillock, M.D.
role: PRINCIPAL_INVESTIGATOR
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