The Use of Barbed Sutures in Total Hip Arthroplasty | NCT02609464

Studies
The Use of Barbed Sutures in Total Hip Arthroplasty

NCT02609464

Sponsor

Rothman Institute Orthopaedics

Status

Completed

Last Update Posted

Sep 8, 2023Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Osteoarthritis, Hip

Interventions

Interrupted Knotted Sutures
STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2015Actual

Primary Completion Date

Mar 1, 2020Actual

Completion Date

Mar 1, 2020Actual

First Submitted Date

Nov 17, 2015

First Submission Date that Met QC Criteria

Nov 18, 2015

First Posted Date

Nov 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2023

Last Update Posted Date

Sep 8, 2023Actual

Name	Class
Ethicon, Inc.	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Inturrupted Knotte Sutures	Active Comparator		Device: Interrupted Knotted Sutures
Barbed Sutures	Active Comparator		Device: STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interrupted Knotted Sutures	Device		Inturrupted Knotte Sutures
STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided