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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01081886
Recruitment Status : Terminated (Termination due to acquisition of PEAK Surgical by Medtronic)
First Posted : March 5, 2010
Results First Posted : January 3, 2013
Last Update Posted : January 8, 2013
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Degenerative Joint Disease Osteoarthritis Device: PEAK PlasmaBlade 4.0 Device: Traditional Electrosurgery with scalpel Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Total Knee Replacement
Study Start Date : June 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PlasmaBlade
The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
Device: PEAK PlasmaBlade 4.0
The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
Other Names:
  • Intervention
  • PlasmaBlade
Active Comparator: Standard of Care
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Device: Traditional Electrosurgery with scalpel
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Other Names:
  • Scalpel and electrosurgery
  • SOC

Primary Outcome Measures :
  1. Post-operative Pain [ Time Frame: 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 :
  1. Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS) [ Time Frame: Intraoperatively and 1-2 weeks postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01081886

United States, Michigan
DeClaire Knee and Orthopedic Institute
Rochester Hills, Michigan, United States, 48307
United States, Texas
Texas Health Arlington Memorial Hospital
Arlington, Texas, United States, 76012
Sponsors and Collaborators
Medtronic Surgical Technologies

Responsible Party: Medtronic Surgical Technologies Identifier: NCT01081886     History of Changes
Other Study ID Numbers: PEAK VP-00082
First Posted: March 5, 2010    Key Record Dates
Results First Posted: January 3, 2013
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Medtronic Surgical Technologies:
Total knee arthroplasty
PEAK Surgical
Medtronic Advanced Energy

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases