NCT03178266

Zip Arthroplasty Patient Satisfaction Evaluation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: ZipLine Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Conditions

• Knee Arthroplasty

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2017-06-06
• Last updated: 2019-05-15
• Results posted: 2019-05-15

Locations

1 site across 1 country: United States