Osteoarthritis Clinical Trial
Official title:
A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Total Knee Replacement
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during total knee replacement; to monitor and record post-operative pain, activity level, narcotic consumption, adverse events, and skin scarring following surgery; and compare these outcomes to the current standard of care (SOC).
Total knee replacement is a surgical procedure performed to replace the weight-bearing
surfaces of the knee joint. The goal of total knee replacement is to improve a patient's
mobility by improving the function of the the knee joint.
The PEAK PlasmaBlade® uses pulsed radiofrequency (RF) energy and a highly-insulated
handpiece design to enable precision cutting and coagulation at the point of application.
The PlasmaBlade has received FDA clearance for use in plastic, general, orthopedic, and ear,
nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury
profile in incised tissue compared to traditional electrosurgical devices. It is
hypothesized that this benefit may improve the post-operative outcome of patients undergoing
total knee replacement.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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