Microcurrent Stimulation Reduces Post-Operative Swelling and Healing Time Following Knee Replacement Surgery
NCT ID: NCT02623660
Last Updated: 2016-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
40 participants
INTERVENTIONAL
2016-01-31
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Antibiotic Elution in Total Knee Arthroplasty
NCT03928522
Antibiotic Elution After Two-stage Knee Revision
NCT06944184
Antibiotic Loaded Cement After TKA
NCT05429671
TKA Operating Room Efficiency for TKA Using Customized Implant Techniques
NCT04180423
Total Knee Arthroplasty (TKA) Cemented Versus Cementless Tibial Prosthesis Study
NCT01041937
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental
This group will receive treatment from the ODIN1 device in conjunction with standard care and diagnostic device testing.
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.
Standard Care
Anti-thrombotic medication. Elevation and ice. Pain medications as needed. Dressings changes. Topical antibiotics. Progressive physical therapy.
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.
Control
This group will receive the standard care and the diagnostic device testing.
Standard Care
Anti-thrombotic medication. Elevation and ice. Pain medications as needed. Dressings changes. Topical antibiotics. Progressive physical therapy.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Standard Care
Anti-thrombotic medication. Elevation and ice. Pain medications as needed. Dressings changes. Topical antibiotics. Progressive physical therapy.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bioelectric Research Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ron Hillock, M.D.
Role: PRINCIPAL_INVESTIGATOR
Centennial Hills Hospital & University of Nevada School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nevada Orthopedic and Spine Center
Las Vegas, Nevada, United States
Centennial Hills Hospital
Las Vegas, Nevada, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1002/aja.1002020202.
Hotary KB, Robinson KR. Endogenous electrical currents and voltage gradients in Xenopus embryos and the consequences of their disruption. Dev Biol. 1994 Dec;166(2):789-800. doi: 10.1006/dbio.1994.1357.
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.
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. doi: 10.1091/mbc.10.4.1259.
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. doi: 10.4049/jimmunol.181.4.2465.
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. doi: 10.1152/physrev.00020.2004.
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.
Li L, Gu W, Du J, Reid B, Deng X, Liu Z, Zong Z, Wang H, Yao B, Yang C, Yan J, Zeng L, Chalmers L, Zhao M, Jiang J. Electric fields guide migration of epidermal stem cells and promote skin wound healing. Wound Repair Regen. 2012 Nov-Dec;20(6):840-51. doi: 10.1111/j.1524-475X.2012.00829.x. Epub 2012 Oct 19.
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. doi: 10.1111/j.1475-097X.2004.00577.x.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BRC-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.