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+InterventionalTreatmentMayo ClinicInvestigator-initiated
~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
Where it's being run
2 sites across 2 statesFlorida1
Minnesota1
Study leadership
- Matthew Abdel, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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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.