Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.

NCT04304885 — Unknown, 56 participants, Bezmialem Vakif University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT04304885
StatusUnknown
Study typeObservational
Enrollment56 (Estimated)
SponsorBezmialem Vakif University (Other)
ConditionsProsthesis-Related Infections, Hip Prosthesis Infection, Joint Infection, Biofilm
InterventionsSonication method (Diagnostic test)
Datesstart 2020-03-15, primary completion 2021-01-15 (estimated), completion 2021-01-15 (estimated), first posted 2020-03-12, last updated 2021-01-07
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Prosthesis-Related Infections All trials for Hip Prosthesis Infection All trials of Sonication method

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Sonication methodDiagnostic Test: Sonication methodThe treatment strategies of all patients will be based on the cultural results to be made by the sonication method.
  • Sonication method (Diagnostic test): Sonication dislodges adherent bacteria from explanted prosthetics by ultrasound and may improve the diagnosis of periprosthetic joint infection.

+Outcome measures

Primary outcomes

  • Sensitivity [14 days]: To determine how many patients diagnosed with periprosthetic joint infection can be detected by sonication method.

Secondary outcomes

  • The change in antibiotic treatment. [14 days]: In how many patients the sonication method will cause a change in treatment.

+Eligibility

Sex: All

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

+Locations (1)

FacilityCityCountryStatus
Bezmialem Vakif UniversityIstanbul, FatihTurkey (Türkiye)Recruiting

+Publications

  • Results publication: 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. PMID 35067748

+Investigators