Symmetric on Total Knee Arthroplasty (TKA) (SFX)

A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Wound Closure Efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Compared to Conventional Sutures in Total Knee Arthroplasty (TKA)

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)

Study Overview

• Status: Completed
• Conditions: Wound Closure
• Intervention / Treatment: Device: "STRATAFIX™ Symmetric" Knotless Tissue; Device: "STRATAFIX Spiral" sutures; Device: DERMABOND™ Advance™ Skin Closure System; Device: VICRYL® PLUS

Detailed Description

The primary objective of this prospective, randomized controlled study is to evaluate the wound closure efficiency of STRATAFIX Symmetric PDS Plus compared to conventional sutures in patients undergoing TKA. For the purpose of this study, wound closure efficiency is defined as the total time required to close the surgical incisions in patients undergoing TKA procedures using STRATAFIX Symmetric PDS Plus compared to those using traditional sutures. Secondary objectives will include the evaluation of differences in overall surgical procedure time, operating room (OR) time, length of stay, procedure costs, quality of life measures including pain, and range of motion (ROM). In addition, the difference in the safety profiles for both wound closure procedures will be evaluated through the analysis of the incidence of wound complications including dehiscence, wound infections, and other adverse events.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Chinese PLA General Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Nanfang Hospital
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Tongji Hospital affiliated Tongji medical college huazhonguniversity of science&technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Jiangsu Province Hospital
  • Jilin
    • Changchun, Jilin, China, 130033
      • Jilin University Chinese Japanese Friendship Hospital
  • Shanxi
    • Xi'an, Shanxi, China, 710004
      • Second Affiliated Hospital of Xi'an JiaoTong University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is ≥ 18 years and < 80 years of age;
2. Patient with osteoarthritis is scheduled to undergo elective unilateral TKA;
3. Patient is willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent; and
4. Patient agrees not to schedule any additional elective surgical procedures until participation in this study is complete.

Exclusion Criteria:

1. Female patient who is pregnant or lactating at the time of screening;
2. Patient has a Body Mass Index (BMI) > 40 kg/m2;
3. Patient is not able to walk independently (inability to walk at least 10 consecutive meters without a walking aid);
4. Patient has had a surgical intervention during the past 30 days for treatment of painful joint or its underlying etiology;
5. Patient has had previous open surgeries on the affected joint other than arthroscopy;
6. Patient has active infectious collagen diseases (i.e. scleroderma) or any other condition that would interfere with wound healing;
7. Patient is allergic to poly (p-dioxanone), triclosan (IRGACARE®* MP) or D&C Violet No. 2;
8. Patient has diabetes with poor control, defined as fasting plasma glucose (FPG) ≥ 10.0 mmol/L;
9. Patient has a history of immunosuppressive drug use, including steroids, within the last 6 months;
10. Patient has undergone chemotherapy or radiation within the last 6 months prior to study enrollment or is scheduled to do so during the study period;
11. Patient has known personal or family history of keloid formation or hypertrophy;
12. Patient has other dermatologic conditions known to impair wound healing;
13. Patient is participating in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study;
14. Patient has any physical or psychological condition which would impair study participation; and
15. Patient is judged unsuitable for study participation by the investigator for any other reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Barbed suture group; The deep layer and the intermediate layer will be repaired and closed by using one "STRATAFIX™ Symmetric" Knotless Tissue suture respectively. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation.	Device: "STRATAFIX™ Symmetric" Knotless Tissue; This devices will be used in deep and intermediate layers of barbed suture group.; Other Names: STRATAFIX Symmetric; Device: "STRATAFIX Spiral" sutures; This devices will be used in intradermal layer of both barbed suture and conventional suture group.; Other Names: Spiral; Device: DERMABOND™ Advance™ Skin Closure System; This devices will be used in skin layer of both barbed suture and conventional suture group.; Other Names: DERMABOND
Active Comparator: Conventional suture group; VICRYL® Plus sutures will be used to close the deep and the intermediate layers with interrupted suturing manner. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation.	Device: "STRATAFIX Spiral" sutures; This devices will be used in intradermal layer of both barbed suture and conventional suture group.; Other Names: Spiral; Device: DERMABOND™ Advance™ Skin Closure System; This devices will be used in skin layer of both barbed suture and conventional suture group.; Other Names: DERMABOND; Device: VICRYL® PLUS; This devices will be used in deep and intermediate layers of conventional suture group.; Other Names: Polyglactin 910

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suturing Time	The total time required to close the surgical incisions between treatment groups.	During Surgery

Collaborators and Investigators

• Sponsor: Johnson & Johnson Medical, China
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Chinese PLA General Hospital; Tongji Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Nanfang Hospital of Southern Medical University; Second Affiliated Hospital of Xi'an Jiaotong University; China-Japan Union Hospital, Jilin University
• Investigators: Study Director: Patty Schleckser, Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2017
• Primary Completion (Actual): April 13, 2018
• Study Completion (Actual): May 21, 2018

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: October 9, 2017
• First Posted (Actual): October 10, 2017

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: December 27, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: TKA; Barbed suture; Surgical time
• Other Study ID Numbers: ESC-16-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes