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

NCT05640336 | Enrolling By Invitation

• 1 other identifier: 22-006739
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 2

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).

Conditions

Periprosthetic Joint Infection

Keywords

Total knee arthroplasty; Total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• Subjects free from failure

  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.

  1 year following DAIR.

Secondary Outcomes (9)

• Readmission within 90 days of the surgical DAIR procedure

  90 days following DAIR procedure

• 1-year surgical reoperation rate

  1 year following DAIR procedure

• 5-year surgical reoperation rate

  5 years following DAIR procedure

• 10-year surgical revision rate

  10 years following DAIR procedure

• Hospital length of stay

  Approximately 2 weeks following DAIR procedure

Study Arms (2)

Single DAIR Surgery Arm

ACTIVE COMPARATOR

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.

Procedure: Single Debridement, Antibiotics and Implant Retention

Double DAIR Surgery Arm

ACTIVE COMPARATOR

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.

Procedure: Planned Double Debridement, Antibiotics and Implant Retention

Interventions

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.

Single DAIR Surgery Arm

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.

Double DAIR Surgery Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Columbia University: collaborator

Study Sites (2)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Debridement; Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Matthew Abdel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: March 3, 2023
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2032
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)