NCT03200470

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prosthetic Joint Infection

Interventions

Type	Name	Description
OTHER	No intervention: sample collection study	Sample collection and collection of laboratory values

Timeline

• Start date: 2017-02-16
• Primary completion: 2018-02-01
• Completion: 2018-03-01
• First posted: 2017-06-27
• Last updated: 2017-10-12

Locations

1 site across 1 country: United States