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Enrolling by Invitation

NCT Number: NCT05640336

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

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).

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Key information

Conditions

Periprosthetic Joint Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single Debridement, Antibiotics and Implant Retention

Procedure

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 oral antibiotic suppression for the life of the implant or at least two years after operation.

Planned Double Debridement, Antibiotics and Implant Retention

Procedure

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 and debrided following a standardized protocol. A six-week course of IV antibiotics will follow the DAIR with additional oral antibiotics for the life of the component (standard of care) or at least a minimum of two years.

Primary outcomes

  1. Subjects free from failure

    Time frame: 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 outcomes

  1. Readmission within 90 days of the surgical DAIR procedure

    Time frame: 90 days following DAIR procedure

    Total number of subjects to required hospital readmission within 90 days of DAIR.

  2. 1-year surgical reoperation rate

    Time frame: 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.

  3. 5-year surgical reoperation rate

    Time frame: 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.

  4. 10-year surgical revision rate

    Time frame: 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.

  5. Hospital length of stay

    Time frame: Approximately 2 weeks following DAIR procedure

    Total number of days subjects were admitted to the hospital

  6. Resource analysis

    Time frame: Approximately 2 weeks following DAIR procedure

    Hospital admission cost comparison between the two study arms

  7. Clinical Outcome Scores

    Time frame: 1, 5, and 10 years following DAIR procedure

    Evaluation of patient reported Harris Hip or Knee Society Scores

  8. Adverse events

    Time frame: 10 years following DAIR procedure

    Total number of subjects to experience adverse events related to either drug or the surgical procedure

  9. Survivorship

    Time frame: 10 years following DAIR procedure

    Total number of subject deaths post-surgical DAIR procedure

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Columbia University

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2032
Study completion
2032
First posted
Dec 7, 2022
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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