The Use of Barbed Sutures in Total Hip Arthroplasty

The Use of Barbed Sutures in Total Hip Arthroplasty: A Prospective, Randomized, and Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Device: Interrupted Knotted Sutures; Device: STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inturrupted Knotte Sutures	Device: Interrupted Knotted Sutures
Active Comparator: Barbed Sutures	Device: STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of suture abscess or other wound related compilation	Within 30 days of surgery

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics
• Collaborators: Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 18, 2015
• First Posted (Estimated): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 15P01