Knee Arthroplasty
Conditions
Brief summary
This study is a prospective, randomized, single center, study to evaluate Zip Closure Device in subjects undergoing knee arthroplasty. Patients identified as candidates for knee arthroplasty and meet the study selection criteria will be approached and considered for the study. Knee Arthroplasty of 40 subjects will be enrolled where 20 subjects will receive ZipLine and 20 subjects will receive Staples.
Detailed description
Sutures and metal staples are considered standard of care methods for surgical skin closure. The Zip® Surgical Skin Closure device from ZipLine Medical, Inc. (Campbell, CA USA) is a more recent method of skin closure that utilizes skin adhesive and adjustable ratcheting straps to achieve and maintain tension necessary for wound closure and healing. The Zip device was designated Class I, 510(k) Exempt by the US FDA in 2010, and the CE Mark was affixed in 2014. Limited patient-reported satisfaction data exists for the Zip device as compared to staples and sutures, so this study will attempt to address this need. The purpose of the study is to evaluate patient satisfaction of closure method used after knee joint arthroplasty. Metal staples and the Zip® Surgical Skin Closure device are approved methods in regular use. Selection of method is generally based on physician preference. This study is to determine what, if any, differences exist in patient satisfaction amongst the two methods
Interventions
DEVICEKnee 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.
Sponsors
ZipLine Medical Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients undergoing primary elective knee arthroplasty. 2. Willing and able to provide informed consent and/or obtain legal guardian authorization 3. Willing and able to comply with the subject-specific requirements outlined in the study protocol
Exclusion criteria
1. Patients that do not meet the conditions listed in the wound closure device warnings, precautions, and contraindications (Appendix A) 2. Patients with comorbidities or conditions that the investigator deems to be ineligible for the study 3. Patients without the capacity to give informed consent (e.g., dementia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) | 6 weeks post knee arthroplasty | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 6 weeks post knee arthroplasty | Subject 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 20 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Disont. Early | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Zip Closure Device | Total | Metal Staples |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 7.13 | 66 years STANDARD_DEVIATION 6.94 | 65 years STANDARD_DEVIATION 6.96 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 41 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 18 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 22 Participants | 3 Participants |
| Region of Enrollment United States | 21 Participants | 41 Participants | 20 Participants |
| Sex: Female, Male Female | 14 Participants | 25 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 16 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 1 / 20 |
| other Total, other adverse events | 2 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 1 / 20 |
Outcome results
Primary
Patient and Observer Scar Assessment Scale (POSAS)
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
Time frame: 6 weeks post knee arthroplasty
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zip Closure Device | Patient and Observer Scar Assessment Scale (POSAS) | Subject Overall Opinion | 2.25 score on a scale | Standard Deviation 1.52 |
| Zip Closure Device | Patient and Observer Scar Assessment Scale (POSAS) | Surgeon Overall Opinion | 1.10 score on a scale | Standard Deviation 0.31 |
| Metal Staples | Patient and Observer Scar Assessment Scale (POSAS) | Subject Overall Opinion | 3.40 score on a scale | Standard Deviation 1.96 |
| Metal Staples | Patient and Observer Scar Assessment Scale (POSAS) | Surgeon Overall Opinion | 2.29 score on a scale | Standard Deviation 1.1 |
Secondary
Patient Satisfaction
Subject 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
Time frame: 6 weeks post knee arthroplasty
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zip Closure Device | Patient Satisfaction | 1.45 score on a scale | Standard Deviation 0.76 |
| Metal Staples | Patient Satisfaction | 1.94 score on a scale | Standard Deviation 0.97 |