NCT01648088

Brief Summary

This study will evaluate which body site(s) provide the best source of possible staph presence in participants undergoing total joint arthroplasty. If the pre-operative cultures indicate staph presence, an Infectious Disease specialist will be consulted for standard of medical care consultation and treatment management. Participants will be followed for 2 years post-implantation of prosthetic joint to monitor development of prosthetic joint infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

June 28, 2012

Last Update Submit

August 30, 2023

Conditions

Surgical Site Infection

Keywords

staphylococcus aureusprosthetic joint implantation

Outcome Measures

Primary Outcomes (1)

  • Development of surgical site infection.

    The patient will be assessed by phone every 6 months for 2 years for development of infection at the surgical site.

    Change in surgical site from baseline at 6 months, 1 year, 18 months and 2 years.

Secondary Outcomes (2)

  • Anatomical site(s) which are best utilized for swab cultures to detect S aureus.

    Up to 24 months post operatively.

  • Post operative infection (s.aureus) development.

    Up to 24 months post operation.

Study Arms (1)

Pre-op THA and TKA patients

Patients who are scheduled for total joint arthroplasty

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing prosthetic joint implantation.

You may qualify if:

  • All adult patients undergoing prosthetic joint implantation

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Surgical Wound InfectionStaphylococcal Infections

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Angela Hewlett, MD, MS

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2012

First Posted

July 24, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations

US(1)