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

NCT05284318 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Fujian Medical University

Phase

Observational

Started

2021-12-01

Last updated

2022-03-17

Condition(s) studied

Periprosthetic Joint InfectionAnti-Bacterial Agents

Investigational drug(s) / intervention(s)

Antibiotics treatment

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

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 not available. 2. Researchers judge that patients no longer meet the standards of the study due to compliance problems

Primary outcome measure(s)

Clearance rate of infection — 31, December，2026
Number of subjects with infection cleared/total number of subjects who completed follow-up

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05284318 on ClinicalTrials.gov ↗ ← All trials in China