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

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ClinicalTrials.gov Identifier: NCT03200470
Recruitment Status : Unknown
Verified October 2017 by Rothman Institute Orthopaedics.
Recruitment status was:  Enrolling by invitation
First Posted : June 27, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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
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
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Study Type : Observational
Estimated 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 : February 16, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2018

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Suspected PJI Other: No intervention: sample collection study
Sample collection and collection of laboratory values


Outcome Measures
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Primary Outcome Measures :
  1. NextGeneration Sequencing analysis concordance with Muskuloskeletal Infection Society (MSIS) criteria for defining infection [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200470


Locations
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United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
Investigators
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Study Chair: Tiffany Morrison, MS, CCRP Rothman Institute
More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT03200470    
Other Study ID Numbers: 2017JPAR
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
 Arthritis
Joint Diseases
Musculoskeletal Diseases