NGS vs Culture Outcomes for Treatment of PJI
Randomized Controlled Trial Investigating the Use of Next-generation Sequencing in Directing the Antimicrobial Treatment of Periprosthetic Joint Infection
1 other identifier
interventional
250
1 country
9
Brief Summary
This multicenter, randomized controlled trial will compare the use of NGS and traditional culture in directing antimicrobial treatment for patients with periprosthetic joint infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Typical duration for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2022
CompletedFirst Posted
Study publicly available on registry
February 18, 2022
CompletedStudy Start
First participant enrolled
September 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedNovember 8, 2023
October 1, 2023
1.6 years
January 13, 2022
November 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants who have been diagnosed with prosthetic joint infection as assessed by the 2018 International Consensus Definition of prosthetic joint infection
Diagnosis of re-infection following surgery and treatment for prosthetic joint infection
90 days from time of surgery
Secondary Outcomes (1)
Number of subjects who have a re-operation as assessed by inpatient hospitalization medical records
one year from time to surgery
Study Arms (2)
Culture-based treatment
ACTIVE COMPARATORNext Generation Sequencing (NGS) with Culture-based treatment
ACTIVE COMPARATORInterventions
Medications to treat prosthetic joint infection will be chosen based on results of traditional cultures alone
Medications to treat prosthetic joint infection will be chosen based results of NGS and culture
Eligibility Criteria
You may qualify if:
- Adults (age \> 18 years)
- Undergoing single stage revision or 1st stage resection arthroplasty/spacer placement for PJI (ICM-positive) of the hip or knee
- Written informed consent
You may not qualify if:
- Ongoing participation in another clinical trial
- Megaprosthesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University of Southern California
Los Angeles, California, 90033, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Columbia University
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14618, United States
Northwell Health
Staten Island, New York, 10309, United States
Cleveland Clinic Ohio
Cleveland, Ohio, 44195, United States
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Study Officials
- STUDY DIRECTOR
Tiffany Morrison
Center for Innovation and Research Organization
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2022
First Posted
February 18, 2022
Study Start
September 21, 2022
Primary Completion
May 1, 2024
Study Completion
May 1, 2025
Last Updated
November 8, 2023
Record last verified: 2023-10