Zip Arthroplasty Patient Satisfaction Evaluation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ZipLine Medical Inc.
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Patient and Observer Scar Assessment Scale (POSAS)
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients undergoing primary elective knee arthroplasty.
- •Willing and able to provide informed consent and/or obtain legal guardian authorization
- •Willing and able to comply with the subject-specific requirements outlined in the study protocol
Exclusion Criteria
- •Patients that do not meet the conditions listed in the wound closure device warnings, precautions, and contraindications (Appendix A)
- •Patients with comorbidities or conditions that the investigator deems to be ineligible for the study
- •Patients without the capacity to give informed consent (e.g., dementia)
Outcomes
Primary Outcomes
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 Outcomes
- Patient Satisfaction(6 weeks post knee arthroplasty)