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This multicenter, randomized controlled trial will compare the use of NGS and traditional culture in directing antimicrobial treatment for patients with periprosthetic joint infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culture-based treatment | Active Comparator |
| |
| Next Generation Sequencing (NGS) with Culture-based treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culture-based treatment | Diagnostic Test | Medications to treat prosthetic joint infection will be chosen based on results of traditional cultures alone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who have a re-operation as assessed by inpatient hospitalization medical records | one year from time to surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany Morrison | Center for Innovation and Research Organization | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Cleveland Clinic Florida |
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| Next Generation Sequencing (NGS) with Culture | Diagnostic Test | Medications to treat prosthetic joint infection will be chosen based results of NGS and culture |
|
| 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 |