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CompletedNCT02609464Updated Sep 8, 2023

The Use of Barbed Sutures in Total Hip Arthroplasty

An interventional study of Interrupted Knotted Sutures and STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices in Osteoarthritis, Hip, sponsored by Rothman Institute Orthopaedics. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by Rothman Institute Orthopaedics · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Osteoarthritis, Hip

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03

In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's enrollment of 100 is above the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Rothman Institute Orthopaedics is the lead sponsor of 118 studies on the registry; 17 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Inturrupted Knotte Sutures

    Device: Interrupted Knotted Sutures

  • Active comparator
    Barbed Sutures

    Device: STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices

Interventions

  • DeviceInterrupted Knotted Sutures
  • DeviceSTRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices
06

What researchers measure

Primary outcomes

  1. Incidence of suture abscess or other wound related compilation

    Time frame: Within 30 days of surgery

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02609464
Lead sponsor
Rothman Institute Orthopaedics
Collaborators
Ethicon, Inc.
Responsible party
Sponsor
First posted
Nov 20, 2015
Start date
Dec 1, 2015
Primary completion
Mar 1, 2020
Completion
Mar 1, 2020
Last update
Sep 8, 2023
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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