Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.

• Conditions: Prosthesis-Related Infections; Hip Prosthesis Infection; Joint Infection; Biofilm
• Interventions: Diagnostic Test: Sonication method

• Registration Number: NCT04304885
• Lead Sponsor: Bezmialem Vakif University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-03-08
• Study First Submitted QC: 2020-03-08
• Study First Posted: 2020-03-12
• Study Start: 2020-03-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-06
• Last Update Posted: 2021-01-07
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sonication method	Sonication method	The treatment strategies of all patients will be based on the cultural results to be made by the sonication method.

Primary Outcome Measures

Name	Time	Method
Sensitivity	14 days	To determine how many patients diagnosed with periprosthetic joint infection can be detected by sonication method.

Secondary Outcome Measures

Name	Time	Method
The change in antibiotic treatment.	14 days	In how many patients the sonication method will cause a change in treatment.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih, Turkey