Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.

• Sponsor: Bezmialem Vakif University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04304885
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Anticipated Duration (Months): 10.1
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prosthesis-Related Infections; Hip Prosthesis Infection; Joint Infection; Biofilm	Diagnostic Test: Sonication method

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 56 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.
• Actual Study Start Date: Mar 15, 2020
• Anticipated Primary Completion Date: Jan 15, 2021
• Anticipated Study Completion Date: Jan 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; Sonication dislodges adherent bacteria from explanted prosthetics by ultrasound and may improve the diagnosis of periprosthetic joint infection.

Outcome Measures

Primary Outcome Measures

1. Sensitivity [14 days]

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

Secondary Outcome Measures

1. The change in antibiotic treatment. [14 days]

   In how many patients the sonication method will cause a change in treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bezmialem Vakif University	Istanbul	Fatih	Turkey	34000

Sponsors and Collaborators

• Bezmialem Vakif University

Investigators

• Principal Investigator: Orkhan Aliyev, MD, Bezmialem Vakif University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Orkhan Aliyev, Residents Doctor in Orthopedics Department, Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT04304885
• Other Study ID Numbers: 28.02.2020-02
• First Posted: Mar 12, 2020
• Last Update Posted: Jan 7, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Orkhan Aliyev, Residents Doctor in Orthopedics Department, Bezmialem Vakif University: total knee arthroplasty; complication; total hip arthroplasty; periprosthetic infection; revision arthroplasty; sonication; biofilm
• Additional relevant MeSH terms: Infections; Communicable Diseases; Arthritis, Infectious; Prosthesis-Related Infections

Study Results

No Results Posted as of Jan 7, 2021