The Utility of Next-generation Sequencing for the Diagnosis of Periprosthetic Joint Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|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|
|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|
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
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|
|Philadelphia, Pennsylvania, United States, 19107|
|Study Chair:||Tiffany Morrison, MS, CCRP||Rothman Institute|