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PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement. (PRECISE)

Primary Purpose

Degenerative Joint Disease, Osteoarthritis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEAK PlasmaBlade 4.0
Traditional Electrosurgery with scalpel
Sponsored by
Medtronic Surgical Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Joint Disease focused on measuring Total knee arthroplasty, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 21 and 80 years old
  2. Physically healthy, stable weight
  3. Requiring unilateral total knee arthroplasty (TKA)
  4. Subject exhibits preoperative radiographic evidence of joint degeneration consistent with TKA that cannot be treated in non-operative fashion
  5. Subject has severe knee pain and disability due to degenerative joint disease
  6. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
  7. Subject must be willing and able to comply with all follow-up evaluations
  8. Subject must be willing to undergo TKA using the Signature Knee System

Exclusion Criteria:

  1. Age younger than 21 or greater than 80 years old
  2. Previous history of infection in the affected joint
  3. Peripheral vascular disease
  4. Revision procedures
  5. BMI > 35
  6. Valgus or varus deformity > 15 degrees
  7. Flexion contracture > 15 degrees
  8. History of diabetes
  9. Anticoagulation therapy which cannot be discontinued
  10. Cognitive impairment or mental illness
  11. Severe cardiopulmonary deficiencies
  12. Known coagulopathy
  13. Immunocompromised
  14. Kidney disease (any type)
  15. Unable to follow instructions or complete follow-up
  16. Currently taking any medication known to affect healing
  17. Currently enrolled in another investigational device or drug trial

Sites / Locations

  • DeClaire Knee and Orthopedic Institute
  • Texas Health Arlington Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PlasmaBlade

Standard of Care

Arm Description

The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.

Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)

Full Information

First Posted
March 4, 2010
Last Updated
January 3, 2013
Sponsor
Medtronic Surgical Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT01081886
Brief Title
PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.
Acronym
PRECISE
Official Title
A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Total Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Termination due to acquisition of PEAK Surgical by Medtronic
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Surgical Technologies

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Joint Disease, Osteoarthritis
Keywords
Total knee arthroplasty, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PlasmaBlade
Arm Type
Experimental
Arm Description
The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Intervention Type
Device
Intervention Name(s)
PEAK PlasmaBlade 4.0
Other Intervention Name(s)
Intervention, PlasmaBlade
Intervention Description
The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
Intervention Type
Device
Intervention Name(s)
Traditional Electrosurgery with scalpel
Other Intervention Name(s)
Scalpel and electrosurgery, SOC
Intervention Description
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Primary Outcome Measure Information:
Title
Post-operative Pain
Description
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.
Time Frame
Postoperative (0 to 10 days)
Secondary Outcome Measure Information:
Title
Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)
Time Frame
Intraoperatively and 1-2 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
DeClaire Knee and Orthopedic Institute
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Texas Health Arlington Memorial Hospital
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States

12. IPD Sharing Statement

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PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.

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