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

Prosthetic Joint Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03200470
• Other study ID #: 2017JPAR
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 20, 2017
• Last updated: October 11, 2017
• Start date: February 16, 2017
• Est. completion date: March 2018

Study information

• Verified date: October 2017
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: March 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infection
• Prosthetic Joint Infection

Intervention

Other:
• No intervention: sample collection study
Sample collection and collection of laboratory values

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

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