Zip Arthroplasty Patient Satisfaction Evaluation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-05-01

Brief Summary

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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.

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Detailed Description

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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

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Knee Arthroplasty

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Zip Closure Device

Patients will receive the Zip Closure Device for final skin closure after knee arthroplasty.

Knee Arthroplasty

Intervention Type 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.

Metal Staples

Patients will receive Metal Staples for final skin closure after knee arthroplasty.

Knee Arthroplasty

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes