Zip IIS vs Standard Closure in Total Hip Arthroplasty

May 1, 2024 updated by: Timothy Damron, M.D., State University of New York - Upstate Medical University
This study will evaluate the outcomes of patients who have had the Zip IIS Line vs standard closure after a total hip replacement (staples for posterior approach THA and monocryl with Prineo mesh for direct anterior approach THA) to determine rate of wound complications, return to OR,readmission for wound related issues, dressing management and cosmesis of wound (Vancouver score)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Since the demand for total joint arthroplasty (TJA) is projected to increase over the next few decades, it is crucial to improve clinical outcomes. In particular, reducing surgical site infections (SSI), a frequent complication following TJA, is of key interest. While patient risk factors and comorbidities may contribute to SSI, modifiable risks factors like closure methods have been associated with decreased incidence of SSIs. Wound closure is commonly achieved using sutures, staples, or skin adhesives. A relatively new zipper-like closure method has been introduced and made commercially available. Previous studies have investigated the incidence of SSIs in patients following total knee arthroplasty (TKA) closed with either conventional closure methods (staples/ sutures) or a zipper device. When compared to conventional methods, results of these studies illustrated either a decrease or no significant change in SSI incidence in the zipper cohort. Although several groups have studied Zipper closure in TKA, there is only one published study, to our knowledge, that has exclusively investigated Zipper closure following total hip arthroplasty (THA). In contrast to the TKA studies, the THA group presented an increased number of SSIs in the Zipper cohort. Due to the lack of published articles and contradicting results, our group intends to add to the field's knowledge of Zipper closure following THA.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must be between ages 18-89
  • must be undergoing a Total Hip replacement

Exclusion Criteria:

  • BMI > 45
  • immunocompromised
  • revision surgery
  • previous surgery
  • cancerous condition
  • malnutrition
  • steroids
  • smoking
  • A1C > 7

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Posterior approach Total Hip Arthroplasty
Subjects will be randomized 1:1, to compare Zipp IIS zip line closure versus staples in a posterior approach total hip arthroplasty
Device: Zip IIS Zip line closure
comparing closure techniques after total hip arthroplasty to determine if one is better than the other
Other Names:
  • standard staples
Active Comparator: Direct Anterior Approach Total Hip Arthroplasty
Subjects will be randomized 1:1, to compare Zipp IIS zip line closure vs monocryl with Prineo sutures in a direct anterior approach total hip arthroplasty
Other: Zip IIS Zip line Closure
comparing closure techniques after total hip arthroplasty to determine if one is better than the other
Other Names:
  • monocryl with Prineo sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate of closure with Zip IIS
Time Frame: 2 years
Comparison of Zip IIS vs sutures
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Upstate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Estimated)

May 2, 2024

Study Record Updates

Last Update Posted (Estimated)

May 2, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2060513

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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