PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.

Stopped early · Not applicable

Conditions studied: Degenerative Joint Disease, Osteoarthritis

In brief

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).

Key facts

Study ID

NCT01081886

Run by

Medtronic Surgical Technologies

People needed

24

Starts

2010-06-01

Expected to finish

2011-09-01

Last updated by the study team

2013-01-08

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• DeClaire Knee and Orthopedic Institute — Rochester Hills, Michigan, United States
• Texas Health Arlington Memorial Hospital — Arlington, Texas, United States

Full record on ClinicalTrials.gov

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