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

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

Study Overview

• Status: Unknown
• Conditions: Prosthetic Joint Infection
• Intervention / Treatment: Other: No intervention: sample collection study

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Samples will be collected from subjects undergoing revision for suspected infection. Data analysis will occur on samples collected

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected PJI	Other: No intervention: sample collection study; Sample collection and collection of laboratory values

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics
• Investigators: Study Chair: Tiffany Morrison, MS, CCRP, Rothman Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2017
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Infections; Communicable Diseases; Arthritis, Infectious
• Other Study ID Numbers: 2017JPAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No