Trial Outcomes & Findings for PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement. (NCT NCT01081886)
NCT ID: NCT01081886
Last Updated: 2013-01-08
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Postoperative (0 to 10 days)
Results posted on
2013-01-08
Participant Flow
Participant milestones
| Measure |
PlasmaBlade
The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
|
Standard of Care (SOC)
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
PlasmaBlade
The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
|
Standard of Care (SOC)
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
|
|---|---|---|
|
Overall Study
Study termination
|
11
|
13
|
Baseline Characteristics
PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.
Baseline characteristics by cohort
| Measure |
PlasmaBlade
n=11 Participants
The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
|
Standard of Care (SOC)
n=13 Participants
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
21 to 80 years
|
11 participants
n=99 Participants
|
13 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Gender
Female
|
NA participants
n=99 Participants
|
NA participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Gender
Male
|
NA participants
n=99 Participants
|
NA participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
13 participants
n=107 Participants
|
24 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Postoperative (0 to 10 days)Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Intraoperatively and 1-2 weeks postoperativelyPopulation: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.
Outcome measures
Outcome data not reported
Adverse Events
PlasmaBlade
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Standard of Care (SOC)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PlasmaBlade
n=11 participants at risk
The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
|
Standard of Care (SOC)
n=13 participants at risk
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Spider bite
|
9.1%
1/11 • Number of events 1
|
0.00%
0/13
|
|
Infections and infestations
Pneumonia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Colitis
|
9.1%
1/11 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/11
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
PlasmaBlade
n=11 participants at risk
The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
|
Standard of Care (SOC)
n=13 participants at risk
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
|
|---|---|---|
|
General disorders
Insomnia
|
0.00%
0/11
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11
|
7.7%
1/13 • Number of events 1
|
|
Surgical and medical procedures
Pain/swelling
|
54.5%
6/11 • Number of events 8
|
30.8%
4/13 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • Number of events 1
|
0.00%
0/13
|
|
Surgical and medical procedures
Effusion
|
18.2%
2/11 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60