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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04666532
Other study ID # JPAR20D165 FARE
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 22, 2020
Est. completion date December 31, 2021

Study information

Verified date December 2020
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Surgical site infections (SSI) are a significant clinical issue that requires the use of a great amount of resources. In particular, periprosthetic joint infections (PJIs) have potentially catastrophic effects on patients' health-related quality of life, function, healthcare costs, outcomes and medical implications. National surveillance estimates may under-report the true incidence and when considering the large number of total hip (THA) and total knee arthroplasty (TKA) procedures performed each year. Patients who have a high-level of nasal bacteria have been found to have a risk of surgical site infection that is three to six times the risk compared with noncarriers and low-level carriers. The association between a patient's nasal carriage of S. aureus, specifically MRSA, and PJI has been demonstrated in a systematic review and confirmed in recent cohort studies. While this association seems to be well accepted, no mechanistic explanation has been provided for this association.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients undergoing revision total knee or total hip arthroplasty at our institution will be eligible Exclusion Criteria: - Patients included in other prospective studies

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary S. aureus Culture and Next Generation Sequencing Diagnostic performance of molecular and culture techniques for S. aureus screening using nasal and groin swabs to determine whether the S. aureus retrieved on the skin and nares of patients who develop a joint infection is identical to the bacteria found in the wound of the PJI 1 day
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