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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zip Closure Device | Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty. |
| |
| Metal Staples | Patients will receive Metal Staples for final skin closure after knee arthroplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knee Arthroplasty | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks post knee arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks post knee arthroplasty |
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Inclusion Criteria:
Exclusion Criteria:
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Candidates for knee arthroplasty
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Menkowitz, MD | Cheif of Surgery and Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montgomery Orthopaedics Associates | Norristown | Pennsylvania | 194001 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks post knee arthroplasty |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Non-systematic Assessment | Cardiac arrest after discharge and before 3 week study visit |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blister lateral to distal end of closure | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Winters, Clinical Project Manager | ZipLine Medical | 4085061866 | wwinters0@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2017 | May 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Withdrawal by Subject |
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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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.
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks post knee arthroplasty |
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|
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| 0 |
| 21 |
| 0 |
| 21 |
| 2 |
| 21 |
| EG001 | 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. | 1 | 20 | 1 | 20 | 0 | 20 |
|
| Serous Drainage | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |