Study Stopped
Termination due to acquisition of PEAK Surgical by Medtronic
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
1 other identifier
interventional
24
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
January 3, 2013
CompletedJanuary 8, 2013
January 1, 2013
1.3 years
March 4, 2010
November 29, 2012
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)
Intraoperatively and 1-2 weeks postoperatively
Study Arms (2)
PlasmaBlade
EXPERIMENTALThe PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
Standard of Care
ACTIVE COMPARATORScalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
DeClaire Knee and Orthopedic Institute
Rochester Hills, Michigan, 48307, United States
Texas Health Arlington Memorial Hospital
Arlington, Texas, 76012, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Upon Medtronic's acquisition of PEAK surgical, a study integrity audit was undertaken. Results of the audit showed that patient's rights and safety were maintained, but the source data, including baseline demographics, were unverifiable.
Results Point of Contact
- Title
- Robert Swain, PhD
- Organization
- Medtronic Surgical Technologies
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2010
First Posted
March 5, 2010
Study Start
June 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
January 8, 2013
Results First Posted
January 3, 2013
Record last verified: 2013-01