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MSSA and MRSA Screening in Patients Undergoing Elective TJA: the Benefits of Next-generation Sequencing

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ClinicalTrials.gov Identifier: NCT04574752
Recruitment Status : Enrolling by invitation
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief Summary:
The aims of this study were to evaluate the diagnostic performance of molecular and culture techniques in S. aureus screening using paired nasal and groin swabs, to determine, if any, discrepancy between the diagnostic techniques and to model the potential effect of different diagnostic techniques on S. aureus detection in orthopaedic patients

Condition or disease Intervention/treatment
Staphylococcus Aureus Next Generation Sequencing Total Joint Arthroplasty Diagnostic Test: next generation sequencing

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Study Type : Observational
Actual Enrollment : 163 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MSSA and MRSA Screening in Patients Undergoing Elective TJA: the Benefits of Next-generation Sequencing
Actual Study Start Date : August 30, 2020
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021

Intervention Details:
  • Diagnostic Test: next generation sequencing
    diagnostic performance of molecular and culture techniques in S. aureus screening using paired nasal and groin swabs, to determine, if any, discrepancy between the diagnostic techniques on S. aureus detection in orthopaedic patients


Primary Outcome Measures :
  1. Diagnostic techniques to identify S. aureus in total joint replacement patients [ Time Frame: 1 day ]
    to model the potential effect of different diagnostic techniques on S. aureus detection in orthopaedic patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing primary total knee or total hip arthroplasty at our institution will be eligible
Criteria

Inclusion Criteria:

  • All patients undergoing primary total knee or total hip arthroplasty at our institution will be eligible.

Exclusion Criteria:

  • Patients included in other prospective studies

Information from the National Library of Medicine

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): NCT04574752


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04574752    
Other Study ID Numbers: JPARV20D.165
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No