Prosthetic Joint Infection
Conditions
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.
Interventions
DIAGNOSTIC_TESTCulture-based treatment
Medications to treat prosthetic joint infection will be chosen based on results of traditional cultures alone
DIAGNOSTIC_TESTNext Generation Sequencing (NGS) with Culture
Medications to treat prosthetic joint infection will be chosen based results of NGS and culture
Sponsors
Center for Innovation and Research Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Ongoing participation in another clinical trial * Megaprosthesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who have been diagnosed with prosthetic joint infection as assessed by the 2018 International Consensus Definition of prosthetic joint infection | 90 days from time of surgery | Diagnosis of re-infection following surgery and treatment for prosthetic joint infection |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects who have a re-operation as assessed by inpatient hospitalization medical records | one year from time to surgery |
Countries
United States
Outcome results
None listed