Zip Arthroplasty Patient Satisfaction Evaluation

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

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)