Zip Arthroplasty Patient Satisfaction Evaluation

Completed

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

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Zip Closure Device	Knee Arthroplasty	Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.
Metal Staples	Knee Arthroplasty	Patients will receive Metal Staples for final skin closure after knee arthroplasty.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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