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Completed

NCT Number: NCT04403919

Knotless Suture in Revision Total Joint Arthroplasty

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.

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Key information

Conditions

Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Conventional Closure: Hip

Device
  • 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).

Barbed suture closure: Hip

Device
  • 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).

Primary outcomes

  1. Time of Closure in Minutes

    Time frame: Up to a maximum of 66 minutes (perioperative)

    Measurement of the time needed to properly close the wound with each technique.

Secondary outcomes

  1. Incidence of Complications Related to Wound Closure

    Time frame: Day 90

    Number of all complications (including needle sticks and glove perforations) and infections related to the wound closure.

  2. Patient and Observer Scar Assessment Scale (POSAS) Score

    Time frame: Week 6 Post-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, which ranges from 0 to 120; higher scores indicate worse scars.

  3. Mean Number of Sutures Used

    Time frame: 45 minutes (perioperative)

  4. Mean Length of Incision

    Time frame: 30 minutes (perioperative)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 27, 2020
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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