Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression
Enrolling by invitation · Not applicable
Conditions studied: Periprosthetic Joint Infection
In brief
The purpose of this research is to evaluate two different standard of care surgeries in treating periprosthetic joint infection (PJI) after total hip and knee arthroplasty. Researchers are looking at differences in outcomes following single versus planned double debridement, antibiotics, and implant retention (DAIR) for acutely infected total hip arthroplasty (THA), and total knee arthroplasties (TKAs).
Key facts
- Study ID
- NCT05640336
- Run by
- Mayo Clinic
- People needed
- 490
- Starts
- 2023-03-03
- Expected to finish
- 2032-03-01
- Last updated by the study team
- 2025-12-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Patients with a chronic PJI, defined as: presentation of symptoms > 4 weeks in duration.
- Revision surgery or previous two-stage reimplantation.
Where it is running
- Mayo Clinic Florida — Jacksonville, Florida, United States
- Mayo Clinic Minnesota — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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