The Utility of Next-generation Sequencing for the Diagnosis of Periprosthetic Joint Infection

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Prosthetic Joint Infection

Treatments: Other: No intervention: sample collection study

Study type: Observational

Funder types: Other

Identifiers

NCT03200470

2017JPAR

Details and patient eligibility

About

This is a prospective multicenter study. All patients presenting for revision hip or knee arthroplasty for all indications under the respective surgeon's care may be eligible. Per standard of care preoperatively, all patients must have blood drawn for erythrocyte sedimentation rate(ESR), C-reactive protein(CRP) and D-dimer. Aspiration of the joint in question may be performed at the discretion of the treating surgeon and results documented. Intraoperative samples will also be collected and sent for NGS analysis

Full description

Pre-operative D-dimer testing should be performed if this is in keeping with the local institutional standard of care. Otherwise, D-dimer testing will be omitted from the pre-operative panel of tests collected.

NGS results will be made available to the Investigator. Treatment will remain within keeping with the Investigator's standard of care. NGS results may be used at the discretion of the treating surgeon in guiding patient treatment.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients undergoing primary total hip or knee arthroplasty with no history of prior surgery
2. Patients undergoing revision hip or knee arthroplasty for septic or aseptic indication.

Exclusion criteria

1. Patients undergoing second stage re-implantation surgery for PJI.

Trial design

120 participants in 1 patient group

Suspected PJI

Treatment:

Other: No intervention: sample collection study