Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06267287 |
| Other study ID # |
2023-4 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
January 2024 |
| Source |
Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
A continuous comparative retrospective study of cases of PJI of the joints of the extremities
with positive microbiological growth of microorganisms in the pre-Covid (2018-2019) and
post-Covid (2021-2022) periods was carried out on the data basis from the medical information
system (MIS) of the Federal Center for Traumatology, Orthopedics and Arthroplasty of Ministry
of Health of Russia (Cheboksary, Russia), hereinafter referred to as the Center.
Verification of the diagnosis of deep PJI was carried out according to the diagnostic
criteria of the Society for Musculoskeletal Infections.
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).
The infection was classified as polymicrobial or monomicrobial. The role of the leading
pathogen was determined in the structure of monomicrobial infection. Polymicrobial infection
is represented by cases of simultaneous isolation of two or more pathogens in one patient.
The antibiotic resistance profile included all isolated pathogens of mono- and polymicrobial
PJI.
At least 4 samples of intraoperative material (tissue biopsies, joint aspirate, removed
endoprosthesis components) were taken from patients for examination.
The aspirate from the joint was placed into FA plus, FN plus bottles of the Bact/Alert 3D
analyzer (Bio Merieux, France). If the sample volume was insufficient (less than 1 ml), it
was inoculated into a vial with Schedler's broth and, when turbid, subcultured onto solid
media.
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. After
ultrasonication, 0.5 ml of the resulting liquid was applied to solid media.
Homogenized tissue samples were placed in broth with thioglycollate medium. The cultures were
incubated at 37°C for up to 14 days, subcultured on solid nutrient media: on the 1st day - on
Columbia, Chocolate and Schedler agars; on the 5th day - on Chocolate and Schedler agar and
on the 10th day - only on Schedler agar. For aerobic, anaerobic and capnophilic
microorganisms, incubation conditions were created using gas-generating packages.
Identification of isolated microorganisms and sensitivity to antibiotics was carried out
using an automatic analyzer (Vitec2 compact; Bio Merieux, France) and a semi-automatic
analyzer (Multiscan FC; Thermo Fisher, USA) using kits (Erba Lachema, Czech Republic), test
systems ("Diagnostic systems", Russia).
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 2018 (studies in 2018-2019), EUCAST 2021 (studies in 2021-2022).
