Skip to main content
OpenTrials
Completed

NCT Number: NCT03178266

Zip Arthroplasty Patient Satisfaction Evaluation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Arthroplasty

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montgomery Orthopaedics Associates

Norristown, Pennsylvania, 194001, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Knee arthroplasty

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ZipLine Medical Inc.

Industry

Registry information

Acronym: ZAPS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2017
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.