The Use of Barbed Sutures in Total Hip Arthroplasty

NCT ID: NCT02609464

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2020-03-01

Brief Summary

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The purpose of this study is to evaluate the role of new barbed suture for closure of wound during total hip arthroplasty in reducing the risk for wound healing problems.

Detailed Description

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Conditions

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Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Inturrupted Knotte Sutures

Group Type ACTIVE_COMPARATOR

Interrupted Knotted Sutures

Intervention Type DEVICE

Barbed Sutures

Group Type ACTIVE_COMPARATOR

STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices

Intervention Type DEVICE

Interventions

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Interrupted Knotted Sutures

Intervention Type DEVICE

STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients receiving elective primary THA through the direct anterior approach, treated by the primary investigator (JP) at the Thomas Jefferson University Hospital or Rothman Specialty Hospital.

Exclusion Criteria

* Prior surgical incision or scar in close proximity of the proposed incision (\<2 cm).
* Local skin conditions such as dermatitis, eczema, or psoriasis.
* Active or previous infection in the skin or the hip.
* Inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical cortico-steroid use
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon, Inc.

INDUSTRY

Sponsor Role collaborator

Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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15P01

Identifier Type: -

Identifier Source: org_study_id

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