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Enrolling by invitation NCT05640336

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

No phase Interventional Periprosthetic Joint Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Single Debridement, Antibiotics and Implant Retention, Planned Double Debridement, Antibiotics and Implant Retention.
Who it may be relevant to
Registry conditions: Periprosthetic Joint Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Single vs Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression for the Treatment of Acute Periprosthetic Joint Infection: A Prospective, Multicenter, Randomized Clinical Trial

Overview

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).

Interventions

  • Procedure Single Debridement, Antibiotics and Implant Retention
    Surgical debridement and wash out of infected joint. The polyethylene (plastic) insert, which acts as the articulating surface (modular component) of the prosthesis, will be removed and the exposed surfaces scrubbed, sterilized, and soaked. A new modular component will be placed with additional irrigation and antiseptic soak. Tissue cultures will be sent to the lab for further evaluation and antibiotic guidance. After the operation subjects will continue six weeks of IV antibiotics followed by o
  • Procedure Planned Double Debridement, Antibiotics and Implant Retention
    Surgical debridement and wash out of infected joint with an additional irrigation and debridement scheduled for approximately 5 days after the initial DAIR. During the first washout, antibiotic cement beads will be placed in the joint and these will remain in the interim until they are removed during the second washout. During the second DAIR, the antibiotic beads are removed, and the modular components are once again removed and replaced with new components. Exposed surfaces are again irrigated

Primary outcome measures

  • Subjects free from failure [Time frame: 1 year following DAIR.]
Secondary outcome measures (9)
  • Readmission within 90 days of the surgical DAIR procedure [Time frame: 90 days following DAIR procedure]
  • 1-year surgical reoperation rate [Time frame: 1 year following DAIR procedure]
  • 5-year surgical reoperation rate [Time frame: 5 years following DAIR procedure]
  • 10-year surgical revision rate [Time frame: 10 years following DAIR procedure]
  • Hospital length of stay [Time frame: Approximately 2 weeks following DAIR procedure]
  • Resource analysis [Time frame: Approximately 2 weeks following DAIR procedure]
  • Clinical Outcome Scores [Time frame: 1, 5, and 10 years following DAIR procedure]
  • Adverse events [Time frame: 10 years following DAIR procedure]
  • Survivorship [Time frame: 10 years following DAIR procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Mayo Clinic Florida — Jacksonville
  • Mayo Clinic Minnesota — Rochester

Identifiers

NCT: NCT05640336 · 22-006739

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗