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

Not Applicable

Interventions: Procedure: Single Debridement, Antibiotics and Implant Retention
Procedure: Planned Double Debridement, Antibiotics and Implant Retention

Brief Summary: 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).

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Single DAIR Surgery Arm	Single Debridement, Antibiotics and Implant Retention	Subjects will undergo a single Debridement Antibiotics and Implant Retention (DAIR) surgical procedure, along with IV antibiotics and followed by oral suppressive antibiotics. This method is currently used and considered to be standard of care.
Double DAIR Surgery Arm	Planned Double Debridement, Antibiotics and Implant Retention	Subjects will undergo planned double Debridement Antibiotics and Implant Retention (DAIR) surgical procedure, along with IV antibiotics and followed by oral suppressive antibiotics. This method is currently used and considered to be standard of care.

Primary Outcome Measures

Name	Time	Method
Subjects free from failure	1 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.

Secondary Outcome Measures

Name	Time	Method
Adverse events	10 years following DAIR procedure	Total number of subjects to experience adverse events related to either drug or the surgical procedure
10-year surgical revision rate	10 years following DAIR procedure	Total number of subjects to require reoperation or revision with or without infection within ten years from the surgical DAIR procedure.
Hospital length of stay	Approximately 2 weeks following DAIR procedure	Total number of days subjects were admitted to the hospital
Resource analysis	Approximately 2 weeks following DAIR procedure	Hospital admission cost comparison between the two study arms
Readmission within 90 days of the surgical DAIR procedure	90 days following DAIR procedure	Total number of subjects to required hospital readmission within 90 days of DAIR.
5-year surgical reoperation rate	5 years following DAIR procedure	Total number of subjects to require reoperation or revision with or without infection within five years from the surgical DAIR procedure.
Survivorship	10 years following DAIR procedure	Total number of subject deaths post-surgical DAIR procedure
1-year surgical reoperation rate	1 year following DAIR procedure	Total number of subjects to require reoperation or revision with or without infection within one year from the surgical DAIR procedure.
Clinical Outcome Scores	1, 5, and 10 years following DAIR procedure	Evaluation of patient reported Harris Hip or Knee Society Scores

Locations (2): Mayo Clinic Florida
🇺🇸
Jacksonville, Florida, United States
Mayo Clinic Minnesota
🇺🇸
Rochester, Minnesota, United States