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

• Sponsor: Rothman Institute Orthopaedics (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03200470
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 12.4
• Patients Per Site Per Month: 9.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Prosthetic Joint Infection	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 Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Utility of Next-generation Sequencing for the Diagnosis of Periprosthetic Joint Infection
• Actual Study Start Date: Feb 16, 2017
• Anticipated Primary Completion Date: Feb 1, 2018
• Anticipated Study Completion Date: Mar 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Rothman Institute Orthopaedics

Investigators

• Study Chair: Tiffany Morrison, MS, CCRP, Rothman Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT03200470
• Other Study ID Numbers: 2017JPAR
• First Posted: Jun 27, 2017
• Last Update Posted: Oct 12, 2017
• Last Verified: Oct 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Arthritis, Infectious

Study Results

No Results Posted as of Oct 12, 2017