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

A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Total Knee Replacement

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).

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Degenerative Joint Disease
• Intervention / Treatment: Device: Traditional Electrosurgery with scalpel; Device: PEAK PlasmaBlade 4.0

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
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Rochester Hills, Michigan, United States, 48307
      • DeClaire Knee and Orthopedic Institute
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Health Arlington Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative (0 to 10 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)	Intraoperatively and 1-2 weeks postoperatively

Collaborators and Investigators

• Sponsor: Medtronic Surgical Technologies

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: March 4, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (Estimate): March 5, 2010

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 3, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; PlasmaBlade; Electrosurgery; PEAK Surgical; Medtronic Advanced Energy; Medtronic
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases
• Other Study ID Numbers: PEAK VP-00082