PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Total Knee Replacement

Conditions
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Degenerative Joint Disease, Osteoarthritis

Intervention / Treatment
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* Device: PEAK PlasmaBlade 4.0
* Device: Traditional Electrosurgery with scalpel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 21 and 80 years old Physically healthy, stable weight Requiring unilateral total knee arthroplasty (TKA) Subject exhibits preoperative radiographic evidence of joint degeneration consistent with TKA that cannot be treated in non-operative fashion Subject has severe knee pain and disability due to degenerative joint disease Subject must understand the nature of the procedure and provide written informed consent prior to the procedure. Subject must be willing and able to comply with all follow-up evaluations Subject must be willing to undergo TKA using the Signature Knee System Exclusion Criteria: Age younger than 21 or greater than 80 years old Previous history of infection in the affected joint Peripheral vascular disease Revision procedures BMI > 35 Valgus or varus deformity > 15 degrees Flexion contracture > 15 degrees History of diabetes Anticoagulation therapy which cannot be discontinued Cognitive impairment or mental illness Severe cardiopulmonary deficiencies Known coagulopathy Immunocompromised Kidney disease (any type) Unable to follow instructions or complete follow-up Currently taking any medication known to affect healing Currently enrolled in another investigational device or drug trial

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PlasmaBlade<br>The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision. | Device: PEAK PlasmaBlade 4.0<br>* The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.<br>* Other names: PlasmaBlade;|
| Active Comparator: Standard of Care<br>Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. | Device: Traditional Electrosurgery with scalpel<br>* Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.<br>* Other names: SOC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Postoperative (0 to 10 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS) |  | Intraoperatively and 1-2 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic