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NCT04304885 Clinical Trial

Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.

Joint Infection Clinical Trial

Official title:
Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04304885
Other study ID # 28.02.2020-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2020
Est. completion date January 15, 2021

Study information
Verified date January 2021
Source Bezmialem Vakif University
Contact Fatih Yildiz, MD
Phone +905059917419
Email yildizfatih@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

It is not known in the literature how much sonication affects the patient's treatment. Another important issue is that the place of this method in diagnosis is not clear. The aim of this study is to contribute to the literature on this issue and to determine the sensitivity and specificity of sonication prospectively using the new definition and effect of sonication on the treatment strategy in terms of infection in patients with PJI.

Description:

Total knee and hip arthroplasties are successful surgical procedures that are widely applied all over the world and provide high patient satisfaction and increased quality of life. Periprosthetic joint infection (PJI), is a serious complication that negatively affects the targeted result, decreases patient satisfaction, and increases morbidity and mortality after total joint replacement. Another important issue, the previous infection is the most important reason for the failure of surgery in revision arthroplasty. It is known that the success of PJI treatment seriously can be affected by the type of microorganism and antibiotic sensitivity. Therefore, microbiological examination methods are always of interest, and one of them is the sonication method.

Recruitment information / eligibility
Status Recruiting
Enrollment 56
Est. completion date January 15, 2021
Est. primary completion date January 15, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients scheduled for revision arthroplasty (aseptic revision, septic revision, instability, and periprosthetic fracture) Exclusion Criteria: - who do not accept to participate in research - insufficient data for new definition criteria - acute periprosthetic infections - patients with systemic inflammatory disease

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Sonication method
Sonication dislodges adherent bacteria from explanted prosthetics by ultrasound and may improve the diagnosis of periprosthetic joint infection.

Locations
Country Name City State
Turkey Bezmialem Vakif University Istanbul Fatih

Sponsors (1)
Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity To determine how many patients diagnosed with periprosthetic joint infection can be detected by sonication method. 14 days
Secondary The change in antibiotic treatment. In how many patients the sonication method will cause a change in treatment. 14 days
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