PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.

Osteoarthritis Clinical Trial

— PRECISE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01081886
• Other study ID #: PEAK VP-00082
• Status: Terminated
• Phase: N/A
• First received: March 4, 2010
• Last updated: January 3, 2013
• Start date: June 2010
• Est. completion date: September 2011

Study information

• Verified date: January 2013
• Source: Medtronic Surgical Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Joint Diseases
• Osteoarthritis

Intervention

Device:
• PEAK PlasmaBlade 4.0
The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
• Traditional Electrosurgery with scalpel
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.

Locations

Country	Name	City	State
United States	Texas Health Arlington Memorial Hospital	Arlington	Texas
United States	DeClaire Knee and Orthopedic Institute	Rochester Hills	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Surgical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)		Intraoperatively and 1-2 weeks postoperatively	No