The Use of STRATAFIX Suture Device Compared to Standard-of-care for Deep Tissue Closure in Total Knee Arthroplasty

NCT03285529 | Completed Results FDA Device

• 1 other identifier: 17-841
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The STRATAFIX (Ethicon, Johnson and Johnson, Somerville, New Jersey) Knotless Tissue Control suture device is a barbed suture that uses anchor technology to securely engage with the soft tissues while also eliminating the need for knots. The anchors, or barbs, are pressed out of the device core or formed within the core in a geometric pattern and arranged in a tapered manner to allow the device to pass through tissue in the direction toward the needle during closure. These knotless tissue control devices are deployed using a continuous technique, which is anticipated to be faster and more cost-effective than interrupted suturing.

Conditions

Wound; Knee

Keywords

barbed suture; knoteless suture; total knee arthroplasty; wound; closure; time

Outcome Measures

Primary Outcomes (1)

• Time to Close, Minutes

  Time from first needle insertion to complete skin closure per protocol

  Day of surgery

Secondary Outcomes (1)

• Number of Participants With Wound Complications

  90 days postoperative

Study Arms (2)

STRATAFIX GROUP

ACTIVE COMPARATOR

STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive

Device: STRATIFIX

CONTROL GROUP

PLACEBO COMPARATOR

The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty.

Device: VICRYL

Interventions

STRATIFIX DEVICE

STRATIFIX symmetric PDS Plus; Stratifix knotless suture

STRATAFIX GROUP

VICRYL DEVICE

Vicryl #1

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, between the ages of 18 to 80 years at the time of signing the informed consent document.
• Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures are conducted.
• Able to adhere to the study visit schedule and other protocol requirements.
• Able to fluently speak and understand the local language
• If female, is non-pregnant (negative pregnancy test results at the baseline/randomization visit) and non-lactating.
• End-stage osteoarthritis patients planning to undergo primary total knee arthroplasty
• BMI less than 40 kg/m2

You may not qualify if:

• BMI greater than or equal to 40 kg/m2.
• History of known bleeding disorder.
• History of medical co-morbidity that may result in poor wound healing (i.e. diabetes mellitus, peripheral vascular disease).
• Patients \<18 or \>80 years of age.
• Patients who are prisoners.
• Mentally unable to sign informed consent.
• Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Sundaram K, Warren JA, Klika A, Piuzzi NS, Mont MA, Krebs V. Barbed sutures reduce arthrotomy closure duration compared to interrupted conventional sutures for total knee arthroplasty: a randomized controlled trial. Musculoskelet Surg. 2021 Dec;105(3):275-281. doi: 10.1007/s12306-020-00654-y. Epub 2020 Mar 7.

  PMID: 32146687 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

• Title: Viktor Krebs
• Organization: Cleveland Clinic

krebsv@ccf.org

216-444-2600

Study Officials

• Viktor Krebs, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman - Adult Reconstruction

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: September 26, 2017
• Primary Completion: February 28, 2019
• Study Completion: May 31, 2019
• Last Updated: November 19, 2020
• Results First Posted: November 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)