PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.
- Conditions
- OsteoarthritisDegenerative Joint Disease
- Interventions
- Device: PEAK PlasmaBlade 4.0Device: Traditional Electrosurgery with scalpel
- Registration Number
- NCT01081886
- Lead Sponsor
- Medtronic Surgical Technologies
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PlasmaBlade PEAK PlasmaBlade 4.0 The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision. Standard of Care Traditional Electrosurgery with scalpel Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
- Primary Outcome Measures
Name Time Method Post-operative Pain Postoperative (0 to 10 days) 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.
- Secondary Outcome Measures
Name Time Method Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS) Intraoperatively and 1-2 weeks postoperatively
Trial Locations
- Locations (2)
DeClaire Knee and Orthopedic Institute
🇺🇸Rochester Hills, Michigan, United States
Texas Health Arlington Memorial Hospital
🇺🇸Arlington, Texas, United States