Knotless Suture in Revision Total Joint Arthroplasty

Overview

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.

Full Title of Study: “Knotless Suture in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2021

Interventions

  • 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.
  • 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.
  • 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).
  • 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).

Arms, Groups and Cohorts

  • Active Comparator: Revision total knee arthroplasty: control
  • Experimental: Revision total knee arthroplasty: active
  • Active Comparator: Revision Total Hip Arthroplasty: control
  • Experimental: Revision Total Hip Arthroplasty: active

Clinical Trial Outcome Measures

Primary Measures

  • Time of closure in seconds
    • Time Frame: 30 minutes (perioperative)
    • Measure the time needed to properly close the wound with each technique

Secondary Measures

  • Incidence of complications related to wound closure
    • Time Frame: 90 Days
    • Record all complications (including needle sticks and glove perforations) and infections related to the wound closure.
  • Difference in cost between conventional and barbed wire closure
    • Time Frame: 90 Days
    • Calculate the cost difference based on supplies, personnel, and OR time between each technique
  • Score on Patient and Observer Scar Assessment Scale (POSAS) between conventional and barbed wire closure
    • Time Frame: 2-6 weeks after surgery
    • 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. This will be assessed at one of the standard of care post-op appointments between 2-6 weeks after surgery.
  • Number of sutures used
    • Time Frame: 30 minutes (perioperative)
  • Length of incision
    • Time Frame: 30 minutes (perioperative)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NYU Langone Health
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ran Schwarzkopf, MD, Principal Investigator, NYU Langone Health
  • Overall Contact(s)
    • Daniel Waren, 212-598-6245, Daniel.waren@nyulangone.org

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