The Utility of Next-generation Sequencing for the Diagnosis of Periprosthetic Joint Infection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prosthetic Joint Infection
- Sponsor
- Rothman Institute Orthopaedics
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- NextGeneration Sequencing analysis concordance with Muskuloskeletal Infection Society (MSIS) criteria for defining infection
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing primary total hip or knee arthroplasty with no history of prior surgery
- •Patients undergoing revision hip or knee arthroplasty for septic or aseptic indication.
Exclusion Criteria
- •Patients undergoing second stage re-implantation surgery for PJI.
Outcomes
Primary Outcomes
NextGeneration Sequencing analysis concordance with Muskuloskeletal Infection Society (MSIS) criteria for defining infection
Time Frame: 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