Symmetric on Total Knee Arthroplasty (TKA)

Summary

A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (STRATAFIX Symmetric PDS Plus) compared to conventional sutures in total knee arthroplasty (TKA)

Conditions

• Wound Closure

Interventions

DEVICE

"STRATAFIX™ Symmetric" Knotless Tissue

This devices will be used in deep and intermediate layers of barbed suture group.

DEVICE

VICRYL® PLUS

This devices will be used in deep and intermediate layers of conventional suture group.

DEVICE

"STRATAFIX Spiral" sutures

This devices will be used in intradermal layer of both barbed suture and conventional suture group.

DEVICE

DERMABOND™ Advance™ Skin Closure System

This devices will be used in skin layer of both barbed suture and conventional suture group.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• China-Japan Union Hospital, Jilin University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Johnson & Johnson Medical, China

  lead INDUSTRY

Principal Investigators

• Patty Schleckser · Ethicon, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-12

Primary Completion

2018-04-13

Completion

2018-05-21

FDA Device

Yes

Countries

• China

Study Locations