Wounds and Injuries Clinical Trial
Official title:
Accelerated Reduction of Post-operative Edema and Early Return to Function Following Total Knee Arthroplasty (TKA)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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