Back to resultsTreatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression
Primary Purpose
Periprosthetic Joint Infection
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single Debridement, Antibiotics and Implant Retention
Planned Double Debridement, Antibiotics and Implant Retention
Sponsored by
About this trial
This is an interventional treatment trial for Periprosthetic Joint Infection focused on measuring Total knee arthroplasty, Total hip arthroplasty
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic Florida
- Mayo Clinic Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single DAIR Surgery Arm
Double DAIR Surgery Arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Readmission within 90 days of the surgical DAIR procedure
Total number of subjects to required hospital readmission within 90 days of DAIR.
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.
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.
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.
Hospital length of stay
Total number of days subjects were admitted to the hospital
Resource analysis
Hospital admission cost comparison between the two study arms
Clinical Outcome Scores
Evaluation of patient reported Harris Hip or Knee Society Scores
Adverse events
Total number of subjects to experience adverse events related to either drug or the surgical procedure
Survivorship
Total number of subject deaths post-surgical DAIR procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05640336
Brief Title
Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 3, 2023 (Actual)
Primary Completion Date
March 2032 (Anticipated)
Study Completion Date
March 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periprosthetic Joint Infection
Keywords
Total knee arthroplasty, Total hip arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
490 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single DAIR Surgery Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Double DAIR Surgery Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Single Debridement, Antibiotics and Implant Retention
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Planned Double Debridement, Antibiotics and Implant Retention
Intervention Description
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 Outcome Measure Information:
Title
Subjects free from failure
Description
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 Outcome Measure Information:
Title
Readmission within 90 days of the surgical DAIR procedure
Description
Total number of subjects to required hospital readmission within 90 days of DAIR.
Time Frame
90 days following DAIR procedure
Title
1-year surgical reoperation rate
Description
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
Title
5-year surgical reoperation rate
Description
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
Title
10-year surgical revision rate
Description
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
Title
Hospital length of stay
Description
Total number of days subjects were admitted to the hospital
Time Frame
Approximately 2 weeks following DAIR procedure
Title
Resource analysis
Description
Hospital admission cost comparison between the two study arms
Time Frame
Approximately 2 weeks following DAIR procedure
Title
Clinical Outcome Scores
Description
Evaluation of patient reported Harris Hip or Knee Society Scores
Time Frame
1, 5, and 10 years following DAIR procedure
Title
Adverse events
Description
Total number of subjects to experience adverse events related to either drug or the surgical procedure
Time Frame
10 years following DAIR procedure
Title
Survivorship
Description
Total number of subject deaths post-surgical DAIR procedure
Time Frame
10 years following DAIR procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Abdel, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression
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