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

• Sponsor: Rothman Institute Orthopaedics (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04574752
• Collaborator: (none)
• Enrollment: 163
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 13.6

Study Details

Study Description

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	Phase
Staphylococcus Aureus; Next Generation Sequencing; Total Joint Arthroplasty	Diagnostic Test: next generation sequencing

Study Design

• 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: Aug 30, 2020
• Anticipated Primary Completion Date: Aug 30, 2021
• Anticipated Study Completion Date: Aug 30, 2021

Outcome Measures

Primary Outcome Measures

1. Diagnostic techniques to identify S. aureus in total joint replacement patients [1 day]

   to model the potential effect of different diagnostic techniques on S. aureus detection in orthopaedic patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT04574752
• Other Study ID Numbers: JPARV20D.165
• First Posted: Oct 5, 2020
• Last Update Posted: Oct 5, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 5, 2020