Clinical trial NCT04304885: Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.
Official title: Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prosthesis-Related Infections
Hip Prosthesis Infection
Joint Infection
Biofilm
Keywords: total knee arthroplasty
complication
total hip arthroplasty
periprosthetic infection
revision arthroplasty
sonication
biofilm
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have undergone primary hip and knee arthroplasty and will require revision for any reason.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity
timeFrame: 14 days
Secondary outcomes:
measure: The change in antibiotic treatment.
timeFrame: 14 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Bezmialem Vakif University
name: Orkhan Aliyev, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.