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Knotless Suture in Revision Total Joint Arthroplasty

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Arthroplasty

Treatments

Device: Barbed suture closure: Knee
Device: Conventional Closure: Knee
Device: Conventional Closure: Hip
Device: Barbed suture closure: Hip

Study type

Interventional

Funder types

Other

Identifiers

NCT04403919
20-00280

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

81 participants in 4 patient groups

Revision total knee arthroplasty: control
Active Comparator group
Treatment:
Device: Conventional Closure: Knee
Revision total knee arthroplasty: active
Experimental group
Treatment:
Device: Barbed suture closure: Knee
Revision Total Hip Arthroplasty: control
Active Comparator group
Treatment:
Device: Conventional Closure: Hip
Revision Total Hip Arthroplasty: active
Experimental group
Treatment:
Device: Barbed suture closure: Hip

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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