Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression

Overview

Información sobre este estudio

The purpose of this study is to evaluate two different standards of care to see if the single Double Debridement, Antibiotics and Implant Retention (DAIR) protocol is non-inferior to planned double-DAIR protocols for acute Periprosthetic Joint Infection (PJI) after primary total hip arthroplasty (THA) or  total knee arthroplasty (TKA). Additionally, effectiveness of treatment in terms of infection eradication and cost comparisons will be addressed.

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria: 

  • Patients ≥ 18 years or older. 
  • Patients who speak English and are willing to sign the consent form
  • Patients with acute early postoperative infection (symptoms ≤ 4 weeks from surgery; symptoms < 4 weeks in duration) and acute hematogenous infection (greater than 3 months from surgery; symptoms < 3 weeks in duration) of a total knee or total hip arthroplasty, defined as:
    • A sinus communicating with the prosthesis OR
    • Two positive cultures obtained from the prosthesis OR
    • 4 of 5 criteria:
      • Elevated ESR (> 30mm/hr) and CRP (> 10mg/L);
      • Elevated synovial leukocyte count (>3000 cells/μL) or change of ++ on;
      • leukocyte esterase strip;
      • Elevated synovial neutrophil percentage (> 80%);
      • One positive culture;
      • Positive histological analysis of periprosthetic tissue (> 5 neutrophils per high;
      • Power field in 5 high power fields x 400).
  • OR Patient with an acute infection diagnosed clinically by an orthopedic surgeon treated with DAIR

Exclusion Criteria:

  • Patients with a chronic PJI, defined as:
    • Presentation of symptoms > 4 weeks in duration.
  • Revision surgery or previous two-stage reimplantation.

Eligibility last updated 6/24/22. Questions regarding updates should be directed to the study team contact.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Matthew Abdel, M.D.

Abierto para la inscripción

Contact information:

Benjamin Mallinger

(507) 293-7918

Mallinger.Benjamin@mayo.edu

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Cameron Ledford, M.D.

Abierto para la inscripción

Contact information:

Stephanie Giles

Giles.Stephanie@mayo.edu

More information

Publicaciones

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CLS-20540755

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