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

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.

Study Overview

• Status: Completed
• Conditions: Wound; Knee
• Intervention / Treatment: Device: STRATIFIX; Device: VICRYL

Detailed Description

Preclinical and biomechanical studies have demonstrated efficacy in cosmetic skin and deep tissue closures.[1], [2] In addition, barbed sutures have been shown to provide water-tight closure and wound strength comparable to or superior to closure with conventional sutures. Many comparative studies have been published contrasting barbed sutures to conventional closure techniques in multiple surgical fields. [3], [4] Various studies have evaluated the outcomes of different barbed suture devices, however there are no reports assessing the length of closure times using STRATAFIX (Ethicon, Johnson and Johnson, Somerville, New Jersey) Knotless Tissue Control Devices during deep closure in total hip arthroplasty. Stephens et al. [5] performed a prospective randomized study of 500 total knee arthroplasty patients who received either barbed suture (250) or conventional sutures (250) for deep closure of the surgical wound. The mean operating time was significantly shorter in the barbed group as compared to conventional group (64.3 vs 68.1 minutes, p=<0.001). In a study of 80 TKA (61 barbed, 19 conventional deep sutures) and 54 THA patients (37 barbed, 17 conventional deep sutures), Smith et al. [6] found significantly shorter closure time in the barbed suture group (16.78 vs. 26.5 minutes, p<0.001). One study reports one the use of Stratfix suture for intracorporeal suturing in myomectomy. Giampaolino et al. [7] performed a prospective randomized study on 47 patients and evaluated the mean operative time for laparoscopic posterior myomectomy using Stratafix or conventional suture for intracorporeal suturing. There was a significant decrease in mean operative time associated with use of Stratafix suture as compared to conventional suture (66.3 vs 73 minutes, p=0.005).

This prospective randomized single-center study will examine the outcomes, mainly closure time, of deep closure during total knee arthroplasty using the STRATAFIX Symmetric PDS Plus (Ethicon, Johnson and Johnson, Somerville, New Jersey) barbed suture compared to interrupted VICRYL suture (Ethicon, Johnson and Johnson, Somerville, New Jersey).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. BMI greater than or equal to 40 kg/m2.
2. History of known bleeding disorder.
3. History of medical co-morbidity that may result in poor wound healing (i.e. diabetes mellitus, peripheral vascular disease).
4. Patients <18 or >80 years of age.
5. Patients who are prisoners.
6. Mentally unable to sign informed consent.
7. 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.

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
Active Comparator: STRATAFIX GROUP; 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; STRATIFIX symmetric PDS Plus; Stratifix knotless suture
Placebo Comparator: CONTROL GROUP; 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; Vicryl #1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Close, Minutes	Time from first needle insertion to complete skin closure per protocol	Day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Wound Complications	superficial wound infection, deep wound infection, periprosthetic joint infection, wound hematoma, and wound dehiscence.	90 days postoperative

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Viktor Krebs, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: total knee arthroplasty; closure; wound; barbed suture; time; knoteless suture
• Other Study ID Numbers: 17-841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No data will be shared with other researchers.

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