Идёт набор NCT05284318

Prospective Cohort Study on Antibiotic Course and Efficacy After Two-stage Revision in PJI.

— Наблюдательное Periprosthetic Joint Infection Anti-Bacterial Agents

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Antibiotics treatment.
Кому может быть актуально: Состояния в реестре: Periprosthetic Joint Infection, Anti-Bacterial Agents. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Antibiotic Treatment Course on Clinical Outcome After Two-stage Revision of Prosthetic Joint Infection: A Prospective Cohort Study.

Обзор

This is a multicenter prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before phase II revision surgery. Eligible patients will be included in this study after signing the informed consent form. After the second stage revision, according to the patient's symptoms and examination results, the attending physician used a reasonable antibiotic treatment scheme (including intravenous and oral medication). All patients voluntarily participated in the study and signed informed consent. During the treatment period, all prospective patients underwent clinical evaluation at the time points of 1, 3, 6, 12, 18 and 24 months after the start of antibiotic treatment after phase II revision. The infection control rate of patients was evaluated by follow-up at least 2 years after operation, so as to analyze the effect of antibiotic treatment course after two-stage revision of periprosthetic joint infection.

Подробное описание

Inclusion criteria：

1. A diagnosis of PJI was made according to MSIS criteria 2. Received spacer implantation and a full course of antibiotic treatment (at least 6 weeks), the patient was clinically determined to have infection control and underwent secondary joint revision. 3. Age ≥18 years old 4. The patient voluntarily participated in the study, and was physically and mentally tolerant to the treatment process and various tests of the study. He has signed an informed consent form and passed the examination of all the hospital ethics committees participating in the study.

Exclusion criteria：

1. Follow up data were not available; 2. The investigator judged that the patient no longer met the criteria of the study due to compliance problems.

Recruiting time：2021.10 -2023.10.31 Interventions Group：No Sample size：500 Study Population Description: Patients who underwent secondary replantation surgery for prosthetic joint infection at the First Affiliated Hospital of Fujian Medical University and other sub-centers were selected.

Вмешательства

Препарат Antibiotics treatment
After receiving intravenous antibiotics treatment for 2 weeks, and clinician determines whether to continue with any antibiotics.

Первичные конечные точки

Clearance rate of infection [Срок оценки: 31, December，2026]

Критерии участия

Критерии включения

\- 1. A diagnosis of PJI was made according to MSIS criteria. 2. Received spacer implantation and a full course of antibiotic treatment (at least 6 weeks), the patient was clinically determined to have infection control and underwent secondary joint revision.

3\. Age ≥18 years old. 4. The patient voluntarily participated in the study, and was physically and mentally tolerant to the treatment process and various tests of the study. He has signed an informed consent form and passed the examination of all the hospital ethics committees participating in the study.