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Zip Arthroplasty Patient Satisfaction Evaluation (ZAPS)

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ClinicalTrials.gov Identifier: NCT03178266
Recruitment Status : Completed
First Posted : June 6, 2017
Results First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
ZipLine Medical Inc.

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.

Condition or disease Intervention/treatment
Knee Arthroplasty Device: Knee Arthroplasty

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


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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Zip Arthroplasty Patient Satisfaction Evaluation
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort Intervention/treatment
Zip Closure Device
Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.
Device: 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.
Device: 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.




Primary Outcome Measures :
  1. Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: 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 Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Candidates for knee arthroplasty
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178266


Locations
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United States, Pennsylvania
Montgomery Orthopaedics Associates
Norristown, Pennsylvania, United States, 194001
Sponsors and Collaborators
ZipLine Medical Inc.
Investigators
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Principal Investigator: Bruce Menkowitz, MD Cheif of Surgery and Orthopaedics
  Study Documents (Full-Text)

Documents provided by ZipLine Medical Inc.:

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Responsible Party: ZipLine Medical Inc.
ClinicalTrials.gov Identifier: NCT03178266     History of Changes
Other Study ID Numbers: 011
First Posted: June 6, 2017    Key Record Dates
Results First Posted: May 15, 2019
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No