Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.

NCT ID: NCT04304885

Last Updated: 2021-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-15

Study Completion Date

2021-01-15

Brief Summary

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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

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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.

Conditions

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Prosthesis-Related Infections Hip Prosthesis Infection Joint Infection Biofilm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sonication method

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

Sonication method

Intervention Type DIAGNOSTIC_TEST

Sonication dislodges adherent bacteria from explanted prosthetics by ultrasound and may improve the diagnosis of periprosthetic joint infection.

Interventions

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Sonication method

Sonication dislodges adherent bacteria from explanted prosthetics by ultrasound and may improve the diagnosis of periprosthetic joint infection.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Orkhan Aliyev

Residents Doctor in Orthopedics Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Orkhan Aliyev, MD

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

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Bezmialem Vakif University

Istanbul, Fatih, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Fatih Yildiz, MD

Role: CONTACT

+905059917419

Facility Contacts

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Orkhan Aliyev

Role: primary

05059917419

References

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Aliyev O, Yildiz F, Kaya HB, Aghazada A, Sumbul B, Citak M, Tuncay I. Sonication of explants enhances the diagnostic accuracy of synovial fluid and tissue cultures and can help determine the appropriate antibiotic therapy for prosthetic joint infections. Int Orthop. 2022 Mar;46(3):415-422. doi: 10.1007/s00264-021-05286-w. Epub 2022 Jan 24.

Reference Type DERIVED
PMID: 35067748 (View on PubMed)

Other Identifiers

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28.02.2020-02

Identifier Type: -

Identifier Source: org_study_id

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