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

Mayo Clinic

Status: Invitation-only

Conditions: Periprosthetic Joint Infection

Treatments: Procedure: Planned Double Debridement, Antibiotics and Implant Retention; Procedure: Single Debridement, Antibiotics and Implant Retention

Study type: Interventional

Funder types: Other

Identifiers

NCT05640336

22-006739

Details and patient eligibility

About

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).

Enrollment: 490 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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490 participants in 2 patient groups

Single DAIR Surgery Arm

Active Comparator group

Description:

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.

Treatment:

Procedure: Single Debridement, Antibiotics and Implant Retention

Double DAIR Surgery Arm

Active Comparator group

Description:

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.

Treatment:

Procedure: Planned Double Debridement, Antibiotics and Implant Retention