- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04574752
MSSA and MRSA Screening in Patients Undergoing Elective TJA: the Benefits of Next-generation Sequencing
September 29, 2020 updated by: Rothman Institute Orthopaedics
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
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
163
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Rothman Orthopaedic Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients undergoing primary total knee or total hip arthroplasty at our institution will be eligible
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2020
Primary Completion (Anticipated)
August 30, 2021
Study Completion (Anticipated)
August 30, 2021
Study Registration Dates
First Submitted
September 29, 2020
First Submitted That Met QC Criteria
September 29, 2020
First Posted (Actual)
October 5, 2020
Study Record Updates
Last Update Posted (Actual)
October 5, 2020
Last Update Submitted That Met QC Criteria
September 29, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- JPARV20D.165
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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