Degenerative Joint DiseasePRECISENCT01081886
PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.
A study testing PEAK PlasmaBlade 4.0 and Traditional Electrosurgery with scalpel in people with Degenerative Joint Disease and Osteoarthritis, run by Medtronic Surgical Technologies at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Degenerative Joint Disease, Osteoarthritis
- What is being tested?
- PEAK PlasmaBlade 4.0 and Traditional Electrosurgery with scalpel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Currently taking any medication known to affect healing
- Currently enrolled in another investigational device or drug trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Health Arlington Memorial Hospital
Arlington, Texas, 76012
DeClaire Knee and Orthopedic Institute
Rochester Hills, Michigan, 48307
About this study
Official title: 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).
Read the 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.
- Conditions
- Degenerative Joint Disease, Osteoarthritis
- Being tested
- PEAK PlasmaBlade 4.0, Traditional Electrosurgery with scalpel
- Keywords
- Total knee arthroplasty, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
- Medical subject headings
- Joint Diseases, Osteoarthritis, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEAK PlasmaBlade 4.0Device
Also called Intervention, PlasmaBlade
The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
Traditional Electrosurgery with scalpelDevice
Also called Scalpel and electrosurgery, SOC
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
| Study group | Role | What they receive |
|---|---|---|
| PlasmaBlade | Experimental | The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision. Receives: Device: PEAK PlasmaBlade 4.0 |
| Standard of Care | Active comparator | Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. Receives: Device: Traditional Electrosurgery with scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative (0 to 10 days)
Secondary outcomes (1)
Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)
Measured: Intraoperatively and 1-2 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Termination due to acquisition of PEAK Surgical by Medtronic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Degenerative Joint DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Surgical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081886
- Sponsor's protocol ID
- PEAK VP-00082
- Acronym
- PRECISE
- Status last verified
- Jan 2013
- First submitted
- 4 Mar 2010
- Last updated
- 8 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01081886
- Acronym / sponsor ID
- PRECISE / PEAK VP-00082
- Conditions
- Degenerative Joint Disease, Osteoarthritis
- Keywords
- Total knee arthroplasty, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination due to acquisition of PEAK Surgical by Medtronic
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medtronic Surgical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Posted 3 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PlasmaBlade | Experimental | Device: PEAK PlasmaBlade 4.0The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision. |
| Standard of Care | Active comparator | Device: Traditional Electrosurgery with scalpelScalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEAK PlasmaBlade 4.0Also: Intervention, PlasmaBladeThe PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision. | Device | PlasmaBlade |
| Traditional Electrosurgery with scalpelAlso: Scalpel and electrosurgery, SOCScalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. | Device | Standard of Care |
Primary outcome
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.
1 secondary outcome
Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)
Time frame: Intraoperatively and 1-2 weeks postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEAK PlasmaBlade 4.0 and Traditional Electrosurgery with scalpel in people with Degenerative Joint Disease and Osteoarthritis, run by Medtronic Surgical Technologies at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pain (time frame: Postoperative (0 to 10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013.