Knotless Suture in Revision Total Joint Arthroplasty

Knotless Suture in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial

Barbed suture has been demonstrated to be safe in primary hip and knee surgery and retrospective data suggests barbed suture represents no increased complications in the revision setting. Barbed suture may represent a faster, more effective way to perform revision arthroplasty closures. There are no Level I studies comparing traditional and barbed suture closure. The purpose of this study is to assess the surgical complexities of closures using closure time without sacrificing cosmesis or wound complications between the traditional closure and barbed closure.

Study Overview

• Status: Completed
• Conditions: Arthroplasty
• Intervention / Treatment: Device: Conventional Closure: Knee; Device: Barbed suture closure: Knee; Device: Conventional Closure: Hip; Device: Barbed suture closure: Hip

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients ≥ 18 years of age
2. Surgical candidates undergoing revision total knee or total hip arthroplasty for one of the following indications second stage of two stage reimplantation for infection, mechanical loosening, instability, polyethylene wear, stiffness, or periprosthetic fracture

Exclusion Criteria:

1. Patient is ≤ 18 years of age
2. Patient is unable to provide written consent
3. Patient has active infections in the operative leg/joint
4. Known Allergy to Suture material
5. Underlying Dermatological diseases affecting surgical site including dermatitis, eczema, or psoriasis; connective tissue or vascular disorders or diseases that would adversely affect wound healing; metastatic cancer; renal insufficiency (dialysis); steroid dependence; malnourishment; and other disease processes resulting in an immunocompromised state. Diabetes, smoking and obesity will be allowed as they are frequent comorbidities in our revision joint population
6. Anterior total hip replacement
7. Stage 1 of two stage revision for infection
8. Closure performed by plastic surgeon, including flap coverage

Vulnerable populations will not be enrolled in this study.

Withdrawal Criteria

1. Failure to attend regularly scheduled follow up appointments
2. Deviation from closure protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Revision total knee arthroplasty: control	Device: Conventional Closure: Knee; Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson & Johnson) and Dermabond advanced.
Experimental: Revision total knee arthroplasty: active	Device: Barbed suture closure: Knee; The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
Active Comparator: Revision Total Hip Arthroplasty: control	Device: Conventional Closure: Hip; The capsule will be closed with Vicryl Plus number 1; Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson &Johnson, Somerville, NJ); Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus); Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson & Johnson); followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson &Johnson).
Experimental: Revision Total Hip Arthroplasty: active	Device: Barbed suture closure: Hip; The capsule will be closed with stratafix symmetric PDS Plus; Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson &Johnson, Somerville, NJ); Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson & Johnson, Somerville, NJ); Subcuticular suture with stratafix spiral monocryl plus, Ethicon; followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson &Johnson).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Closure in Minutes	Measurement of the time needed to properly close the wound with each technique.	Up to a maximum of 66 minutes (perioperative)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Complications Related to Wound Closure	Number of all complications (including needle sticks and glove perforations) and infections related to the wound closure.	Day 90
Patient and Observer Scar Assessment Scale (POSAS) Score	The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale, where 0 = normal skin and 10 = worst scar imaginable. Together they make up the 'Total Score' of the Patient and Observer Scale, which ranges from 0 to 120; higher scores indicate worse scars.	Week 6 Post-Surgery
Mean Number of Sutures Used		45 minutes (perioperative)
Mean Length of Incision		30 minutes (perioperative)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Ran Schwarzkopf, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20-00280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Requests should be directed to ran.schwarzkopf@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

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