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

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05640336

Collaborator

(none)

490

Enrollment

Locations

Arms

118

Anticipated Duration (Months)

245

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Periprosthetic Joint Infection	Procedure: Single Debridement, Antibiotics and Implant Retention Procedure: Planned Double Debridement, Antibiotics and Implant Retention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

490 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2032

Anticipated Study Completion Date :

Dec 1, 2032

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single DAIR Surgery Arm 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 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.
Active Comparator: Double DAIR Surgery Arm 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 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.

Arm

Intervention/Treatment

Active Comparator: Single DAIR Surgery Arm

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

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.

Active Comparator: Double DAIR Surgery Arm

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

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.

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
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
Clinical Outcome Scores [1, 5, and 10 years following DAIR procedure]
Evaluation of patient reported Harris Hip or Knee Society Scores
Adverse events [10 years following DAIR procedure]
Total number of subjects to experience adverse events related to either drug or the surgical procedure
Survivorship [10 years following DAIR procedure]
Total number of subject deaths post-surgical DAIR procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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