Trial Outcomes & Findings for Zip Arthroplasty Patient Satisfaction Evaluation (NCT NCT03178266)
NCT ID: NCT03178266
Last Updated: 2019-05-15
Results Overview
The subject and investigator will rate commonly described scar characteristics from a patient and observers perspective Subject and Physician will rate overall opinion of scar to normal skin where 1-Normal to 10-Very Different
Recruitment status
COMPLETED
Target enrollment
41 participants
Primary outcome timeframe
6 weeks post knee arthroplasty
Results posted on
2019-05-15
Participant Flow
Participant milestones
| Measure |
Zip Closure Device
Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
Metal Staples
Patients will receive Metal Staples for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
21
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Zip Closure Device
Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
Metal Staples
Patients will receive Metal Staples for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Disont. Early
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Zip Arthroplasty Patient Satisfaction Evaluation
Baseline characteristics by cohort
| Measure |
Zip Closure Device
n=21 Participants
Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
Metal Staples
n=20 Participants
Patients will receive Metal Staples for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 7.13 • n=5 Participants
|
65 years
STANDARD_DEVIATION 6.96 • n=7 Participants
|
66 years
STANDARD_DEVIATION 6.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post knee arthroplastyThe subject and investigator will rate commonly described scar characteristics from a patient and observers perspective Subject and Physician will rate overall opinion of scar to normal skin where 1-Normal to 10-Very Different
Outcome measures
| Measure |
Zip Closure Device
n=21 Participants
Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
Metal Staples
n=16 Participants
Patients will receive Metal Staples for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
|---|---|---|
|
Patient and Observer Scar Assessment Scale (POSAS)
Subject Overall Opinion
|
2.25 score on a scale
Standard Deviation 1.52
|
3.40 score on a scale
Standard Deviation 1.96
|
|
Patient and Observer Scar Assessment Scale (POSAS)
Surgeon Overall Opinion
|
1.10 score on a scale
Standard Deviation 0.31
|
2.29 score on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: 6 weeks post knee arthroplastySubject Experience and Satisfaction results at 6 weeks post procedure. Subjects are asked of satisfaction with scar appearance on a scale of 1-minimal scar to 5-significant scar
Outcome measures
| Measure |
Zip Closure Device
n=21 Participants
Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
Metal Staples
n=16 Participants
Patients will receive Metal Staples for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
|---|---|---|
|
Patient Satisfaction
|
1.45 score on a scale
Standard Deviation 0.76
|
1.94 score on a scale
Standard Deviation 0.97
|
Adverse Events
Zip Closure Device
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Metal Staples
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Zip Closure Device
n=21 participants at risk
Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
Metal Staples
n=20 participants at risk
Patients will receive Metal Staples for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
|---|---|---|
|
Cardiac disorders
Death
|
0.00%
0/21 • 6 weeks
|
5.0%
1/20 • Number of events 1 • 6 weeks
|
Other adverse events
| Measure |
Zip Closure Device
n=21 participants at risk
Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
Metal Staples
n=20 participants at risk
Patients will receive Metal Staples for final skin closure after knee arthroplasty.
Knee Arthroplasty: Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Blister lateral to distal end of closure
|
4.8%
1/21 • Number of events 1 • 6 weeks
|
0.00%
0/20 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Serous Drainage
|
4.8%
1/21 • Number of events 1 • 6 weeks
|
0.00%
0/20 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place