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

• Conditions: Prosthetic Joint Infection

• Registration Number: NCT03200470
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-02-16
• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-27
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12
• Primary Completion: 2018-02
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NextGeneration Sequencing analysis concordance with Muskuloskeletal Infection Society (MSIS) criteria for defining infection	Immediate post-operative period (usually within 5 days following surgery)	MSIS criteria incorporates pre-operative laboratory values with tissue and fluid samples collected during surgery in an attempt to diagnose infection

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States