NGS vs Culture Outcomes for Treatment of PJI

Center for Innovation and Research Organization

Status: Invitation-only

Conditions: Prosthetic Joint Infection

Treatments: Diagnostic Test: Next Generation Sequencing (NGS) with Culture; Diagnostic Test: Culture-based treatment

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05247281

2022NGSOutcomes

Details and patient eligibility

About

This multicenter, randomized controlled trial will compare the use of NGS and traditional culture in directing antimicrobial treatment for patients with periprosthetic joint infection.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Culture-based treatment

Active Comparator group

Treatment:

Diagnostic Test: Culture-based treatment

Next Generation Sequencing (NGS) with Culture-based treatment

Active Comparator group

Treatment:

Diagnostic Test: Next Generation Sequencing (NGS) with Culture