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
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Condition or disease | Intervention/treatment |
---|---|
Prosthetic Joint Infection | Other: No intervention: sample collection study |
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 |
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 |

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

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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 |
Inclusion Criteria:
- Patients undergoing primary total hip or knee arthroplasty with no history of prior surgery
- Patients undergoing revision hip or knee arthroplasty for septic or aseptic indication.
Exclusion Criteria:
1. Patients undergoing second stage re-implantation surgery for PJI.

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
United States, Pennsylvania | |
Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
Study Chair: | Tiffany Morrison, MS, CCRP | Rothman Institute |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Infections Communicable Diseases Arthritis, Infectious Disease Attributes |
Pathologic Processes Arthritis Joint Diseases Musculoskeletal Diseases |