NCT01081886

PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Medtronic Surgical Technologies · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Joint Disease
• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	PEAK PlasmaBlade 4.0	The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
DEVICE	Traditional Electrosurgery with scalpel	Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2010-03-05
• Last updated: 2013-01-08
• Results posted: 2013-01-03

Locations

2 sites across 1 country: United States