Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period

NCT06267287 | Completed DMC

• 1 other identifier: 2023-4
• Study Type: observational
• Target: 342
• Locations: 1 country
• Sites: 1

Brief Summary

Background. Infection is the most common complication of complications after joint arthroplasty. During the COVID-19 pandemic increased used antibacterial drugs by adults, this could change the spectrum of infectious agents and their antimicrobial resistance. The purpose of the study is to evaluate the microbial diversity of pathogens of periprosthetic infection in the pre- and post-Covid period, determining the sensitivity of the leading pathogens to antibiotics. Materials and methods. A comprehensive comparative retrospective study was carried out on 342 cases of monomicrobial and polymicrobial periprosthetic infection (PPI) of limb joints with microbiological growth of microorganisms in the pre-Covid (2018-2019) and post-Covid (2021-2022) periods.

Conditions

Joint Infection; Periprosthetic Left Knee Joint Infection

Keywords

periprosthetic infection; antibiotic resistance; Staphylococcus epidermidis; pathogens of periprosthetic infection; COVID-19; empirical antibiotic therapy

Outcome Measures

Primary Outcomes (2)

• Structure of isolated pathogens of periprosthetic infection

  The proportion of identified microorganisms in the general structure of pathogens of periprosthetic infection

  2018-2019

• Structure of isolated pathogens of periprosthetic infection

  The proportion of identified microorganisms in the general structure of pathogens of periprosthetic infection

  2021-2022

Secondary Outcomes (2)

• Antibiotic resistance of isolated pathogens of periprosthetic infection

  2018-2019

• Antibiotic resistance of isolated pathogens of periprosthetic infection

  2021-2022

Study Arms (2)

cases of PJI 2018-2019

All cases of monomicrobial and polymicrobial periprocthetic infection for 2018-2019. Microbiological identification of pathogens of periprosthetic infections and determination of their sensitivity to antibiotics.

Diagnostic Test: Microbiological examination of the patient's biological material and determination of antibiotic resistance

cases of PJI 2021-2022

All cases of monomicrobial and polymicrobial periprocthetic infection for 2021-2022. Microbiological identification of pathogens of periprosthetic infections and determination of their sensitivity to antibiotics.

Diagnostic Test: Microbiological examination of the patient's biological material and determination of antibiotic resistance

Interventions

Microbiological examination of the patient's biological material and determination of antibiotic resistance DIAGNOSTIC_TEST

Isolated microorganisms were identified based on growth in one or more cultures obtained from punctate synovial fluid, intraoperative tissues, and from removed implants (after their ultrasonic treatment). At least 4 samples of intraoperative material (tissue biopsies, joint aspirate, removed endoprosthesis components) were taken from patients for examination. The endoprosthesis components removed during surgery were placed in a sterile plastic container and delivered to the laboratory. In the laboratory, saline solution was added to the container and processed in an ultrasonic machine according to the author's method. Identification of isolated microorganisms and sensitivity to antibiotics was carried out using an automatic analyzer and a semi-automatic analyzer using kits, test systems. Sensitivity to antibacterial drugs was tested using the disk diffusion method and analyzer kits. Antibiotic sensitivity assessment was carried out in accordance with the criteria of EUCAST.

Also known as: Identification of the infectious agent and determination of antibiotic resistance

cases of PJI 2018-2019; cases of PJI 2021-2022

Eligibility Criteria

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

Study Population

The sample included cases of deep and superficial infection after arthroplasty of the knee, hip, shoulder and wrist joints, regardless of the location of the primary operation. Isolated microorganisms were identified based on growth in one or more cultures obtained from punctate synovial fluid, intraoperative tissues, and from removed implants (after their ultrasonic treatment).

You may qualify if:

• Clinically confirmed periprosthetic infection

You may not qualify if:

• No signs of periprosthetic infection

Sponsors & Collaborators

• Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty: lead

Study Sites (1)

Federal Center for Traumatology, Orthopedics and Endoprosthetics

Cheboksary, Chuvashskaya Respublika, 429500, Russia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 20, 2024
• Study Start: January 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-01

Locations

RU (1)