Microcurrent Stimulation Reduces Post-Operative Swelling and Healing Time Following Knee Replacement Surgery
Status unconfirmed · Not applicable
Conditions studied: Osteoarthritis of Knee, Edema, Wounds and Injuries
In brief
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.
Key facts
- Study ID
- NCT02623660
- Run by
- Bioelectric Research Corporation
- People needed
- 40
- Starts
- 2016-01-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2016-01-12
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Nevada Orthopedic and Spine Center — Las Vegas, Nevada, United States
- Centennial Hills Hospital — Las Vegas, Nevada, United States
Full record on ClinicalTrials.gov
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