Zip IIS vs Standard Closure in Total Hip Arthroplasty

State University of New York - Upstate Medical University

Status: Not yet enrolling

Conditions: Total Hip Arthroplasy

Treatments: Device: Zip IIS Zip line closure; Other: Zip IIS Zip line Closure

Study type: Interventional

Funder types: Other

Identifiers

NCT06396052

2060513

Details and patient eligibility

About

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)

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Posterior approach Total Hip Arthroplasty

Active Comparator group

Description:

Subjects will be randomized 1:1, to compare Zipp IIS zip line closure versus staples in a posterior approach total hip arthroplasty

Treatment:

Device: Zip IIS Zip line closure

Direct Anterior Approach Total Hip Arthroplasty

Active Comparator group

Description:

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

Treatment:

Other: Zip IIS Zip line Closure