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PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.

NCT01081886 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-01-08

Study results available
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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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medtronic Surgical Technologies

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01081886 on ClinicalTrials.gov