Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.

NCT04304885 | Unknown

• 1 other identifier: 28.02.2020-02
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthesis-Related Infections; Hip Prosthesis Infection; Joint Infection; Biofilm

Keywords

total knee arthroplasty; complication; total hip arthroplasty; periprosthetic infection; revision arthroplasty; sonication; biofilm

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  To determine how many patients diagnosed with periprosthetic joint infection can be detected by sonication method.

  14 days

Secondary Outcomes (1)

• The change in antibiotic treatment.

  14 days

Study Arms (1)

Sonication method

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

Diagnostic Test: Sonication method

Interventions

Sonication method DIAGNOSTIC_TEST

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

Sonication method

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have undergone primary hip and knee arthroplasty and will require revision for any reason.

You may qualify if:

• All patients scheduled for revision arthroplasty (aseptic revision, septic revision, instability, and periprosthetic fracture)

You may not qualify if:

• who do not accept to participate in research
• insufficient data for new definition criteria
• acute periprosthetic infections
• patients with systemic inflammatory disease

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Prosthesis-Related Infections

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Orkhan Aliyev, MD

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatih Yildiz, MD

CONTACT

+905059917419; yildizfatih@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residents Doctor in Orthopedics Department

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 12, 2020
• Study Start: March 15, 2020
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)