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

N/AEnrolling By InvitationNCT05640336

Mayo Clinic490 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

490

Conditions

Periprosthetic Joint Infection

Interventions

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 RetentionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Mayo Clinic Florida

Jacksonville, Florida, United States

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 year following DAIR.

Secondary Outcomes

Readmission within 90 days of the surgical DAIR procedure

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

Time frame: 90 days following DAIR procedure

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.

Time frame: 1 year following DAIR procedure

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.

Time frame: 5 years following DAIR procedure

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.

Time frame: 10 years following DAIR procedure

Hospital length of stay

Total number of days subjects were admitted to the hospital

Time frame: Approximately 2 weeks following DAIR procedure

Resource analysis

Hospital admission cost comparison between the two study arms

Time frame: Approximately 2 weeks following DAIR procedure

Clinical Outcome Scores

Evaluation of patient reported Harris Hip or Knee Society Scores

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

Adverse events

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

Time frame: 10 years following DAIR procedure

Survivorship

Total number of subject deaths post-surgical DAIR procedure

Time frame: 10 years following DAIR procedure