NCT02609464

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

4.3 years

First QC Date

November 17, 2015

Last Update Submit

September 5, 2023

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

  • Incidence of suture abscess or other wound related compilation

    Within 30 days of surgery

Study Arms (2)

Inturrupted Knotte Sutures

ACTIVE COMPARATOR
Device: Interrupted Knotted Sutures

Barbed Sutures

ACTIVE COMPARATOR
Device: STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices

Interventions

Interrupted Knotted SuturesDEVICE
Inturrupted Knotte Sutures
STRATAFIX Symmetric PDS PLUS Knotless Tissue Control DevicesDEVICE
Barbed Sutures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 20, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

September 8, 2023

Record last verified: 2023-09