Zip Arthroplasty Patient Satisfaction Evaluation

NCT03178266 | Completed Results

• 1 other identifier: 011
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Patient and Observer Scar Assessment Scale (POSAS)

  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

  6 weeks post knee arthroplasty

Secondary Outcomes (1)

• Patient Satisfaction

  6 weeks post knee arthroplasty

Study Arms (2)

Zip Closure Device

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

Device: Knee Arthroplasty

Metal Staples

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

Device: Knee Arthroplasty

Interventions

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.

Metal Staples; Zip Closure Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Candidates for knee arthroplasty

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• ZipLine Medical Inc.: lead

Study Sites (1)

Montgomery Orthopaedics Associates

Norristown, Pennsylvania, 194001, United States

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Wendy Winters, Clinical Project Manager
• Organization: ZipLine Medical

wwinters0@gmail.com

4085061866

Study Officials

• Bruce Menkowitz, MD

  Cheif of Surgery and Orthopaedics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: December 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 15, 2019
• Results First Posted: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)