Prosthetic Joint Infection
Conditions
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.
Interventions
OTHERNo intervention: sample collection study
Sample collection and collection of laboratory values
Sponsors
Rothman Institute Orthopaedics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed