Back to resultsThe Use of Barbed Sutures in Total Hip Arthroplasty
Primary Purpose
Osteoarthritis, Hip
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interrupted Knotted Sutures
STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Inturrupted Knotte Sutures
Barbed Sutures
Arm Description
Outcomes
Primary Outcome Measures
Incidence of suture abscess or other wound related compilation
Secondary Outcome Measures
Full Information
NCT ID
NCT02609464
First Posted
November 17, 2015
Last Updated
September 5, 2023
Sponsor
Rothman Institute Orthopaedics
Collaborators
Ethicon, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02609464
Brief Title
The Use of Barbed Sutures in Total Hip Arthroplasty
Official Title
The Use of Barbed Sutures in Total Hip Arthroplasty: A Prospective, Randomized, and Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
Collaborators
Ethicon, Inc.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inturrupted Knotte Sutures
Arm Type
Active Comparator
Arm Title
Barbed Sutures
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Interrupted Knotted Sutures
Intervention Type
Device
Intervention Name(s)
STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices
Primary Outcome Measure Information:
Title
Incidence of suture abscess or other wound related compilation
Time Frame
Within 30 days of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
The Use of Barbed Sutures in Total Hip Arthroplasty
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