Knotless Suture in Revision Total Joint Arthroplasty

NCT04403919 | Completed Results DMC FDA Device

• 1 other identifier: 20-00280
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of Complications Related to Wound Closure

  Day 90

• Patient and Observer Scar Assessment Scale (POSAS) Score

  Week 6 Post-Surgery

• Mean Number of Sutures Used

  45 minutes (perioperative)

• Mean Length of Incision

  30 minutes (perioperative)

Study Arms (4)

Revision total knee arthroplasty: control

ACTIVE COMPARATOR

Device: Conventional Closure: Knee

Revision total knee arthroplasty: active

EXPERIMENTAL

Device: Barbed suture closure: Knee

Revision Total Hip Arthroplasty: control

ACTIVE COMPARATOR

Device: Conventional Closure: Hip

Revision Total Hip Arthroplasty: active

EXPERIMENTAL

Device: Barbed suture closure: Hip

Interventions

Conventional Closure: Knee DEVICE

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.

Revision total knee arthroplasty: control

Barbed suture closure: Knee DEVICE

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.

Revision total knee arthroplasty: active

Conventional Closure: Hip DEVICE

1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).

Revision Total Hip Arthroplasty: control

Barbed suture closure: Hip DEVICE

1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).

Revision Total Hip Arthroplasty: active

Eligibility Criteria

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

You may qualify if:

• Patients ≥ 18 years of age
• 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

You may not qualify if:

• Patient is ≤ 18 years of age
• Patient is unable to provide written consent
• Patient has active infections in the operative leg/joint
• Known Allergy to Suture material
• 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
• Anterior total hip replacement
• Stage 1 of two stage revision for infection
• Closure performed by plastic surgeon, including flap coverage
• Vulnerable populations will not be enrolled in this study.
• Withdrawal Criteria
• Failure to attend regularly scheduled follow up appointments
• Deviation from closure protocol

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Results Point of Contact

• Title: Ran Schwarzkopf, MD
• Organization: NYU Langone Health

Ran.Schwarzkopf@nyulangone.org

646-501-7070

Study Officials

• Ran Schwarzkopf, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized, controlled trial, parallel four-arm design, single-center study

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 27, 2020
• Study Start: September 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: Requests should be directed to ran.schwarzkopf@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)