Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Termination due to acquisition of PEAK Surgical by Medtronic)
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies
ClinicalTrials.gov Identifier:
NCT01081886
First received: March 4, 2010
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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 Intervention
Degenerative Joint Disease
Osteoarthritis
Device: PEAK PlasmaBlade 4.0
Device: Traditional Electrosurgery with scalpel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Total Knee Replacement

Resource links provided by NLM:


Further study details as provided by Medtronic Surgical Technologies:

Primary Outcome Measures:
  • Post-operative Pain [ Time Frame: Postoperative (0 to 10 days) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Intraoperatively and 1-2 weeks postoperatively ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081886

Locations
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
  More Information

No publications provided

Responsible Party: Medtronic Surgical Technologies
ClinicalTrials.gov Identifier: NCT01081886     History of Changes
Other Study ID Numbers: PEAK VP-00082
Study First Received: March 4, 2010
Results First Received: November 29, 2012
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2014