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

Periprosthetic Joint Infection Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05640336
• Other study ID #: 22-006739
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 3, 2023
• Est. completion date: March 2032

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 490
• Est. completion date: March 2032
• Est. primary completion date: March 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infections
• Periprosthetic Joint Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Readmission within 90 days of the surgical DAIR procedure	Total number of subjects to required hospital readmission within 90 days of DAIR.	90 days following DAIR procedure
Secondary	1-year surgical reoperation rate	Total number of subjects to require reoperation or revision with or without infection within one year from the surgical DAIR procedure.	1 year following DAIR procedure
Secondary	5-year surgical reoperation rate	Total number of subjects to require reoperation or revision with or without infection within five years from the surgical DAIR procedure.	5 years following DAIR procedure
Secondary	10-year surgical revision rate	Total number of subjects to require reoperation or revision with or without infection within ten years from the surgical DAIR procedure.	10 years following DAIR procedure
Secondary	Hospital length of stay	Total number of days subjects were admitted to the hospital	Approximately 2 weeks following DAIR procedure
Secondary	Resource analysis	Hospital admission cost comparison between the two study arms	Approximately 2 weeks following DAIR procedure
Secondary	Clinical Outcome Scores	Evaluation of patient reported Harris Hip or Knee Society Scores	1, 5, and 10 years following DAIR procedure
Secondary	Adverse events	Total number of subjects to experience adverse events related to either drug or the surgical procedure	10 years following DAIR procedure
Secondary	Survivorship	Total number of subject deaths post-surgical DAIR procedure	10 years following DAIR procedure