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

Overview

About this study

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.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Abdel, M.D.

Open for enrollment

Contact information:

Benjamin Mallinger

(507) 293-7918

Mallinger.Benjamin@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Cameron Ledford, M.D.

Open for enrollment

Contact information:

Stephanie Giles

Giles.Stephanie@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20540755

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