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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
DeClaire Knee and Orthopedic Institute
Rochester Hills, Michigan, United States
Texas Health Arlington Memorial Hospital
Arlington, Texas, United States
Post-operative Pain
Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.
Time frame: Postoperative (0 to 10 days)
Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)
Time frame: Intraoperatively and 1-2 weeks postoperatively
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