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NCT05640336

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

Enrolling by Invitation
NAAges 18+InterventionalTreatment
Mayo Clinic
~490 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:Single Debridement, Antibiotics and Implant RetentionPlanned Double Debridement, Antibiotics and Implant Retention

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Subjects free from failure
Measured over 1 year following DAIR.

Conditions

Periprosthetic Joint Infection

Explore related trials

Peri-prosthetic Joint InfectionTotal Knee ReplacementTotal replacement of hip

NCT05640336

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic Florida

    Jacksonville, Floridano site contact published

  • Mayo Clinic Minnesota

    Rochester, Minnesotano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Matthew Abdel, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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 4 weeks from surgery; symptoms \< 3 weeks in duration) of a primary 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

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

What this trial measures

  • Subjects free from failure1 year following DAIR.

    Total number of subjects considered failure free at one year from surgical DAIR procedure. Failure is defined as reoperation for infection within one year from surgical procedure.