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The clinical value of precise diagnosis system for pathogenic bacteria in the treatment of PJI: a prospective, randomized controlled trial

The clinical value of precise diagnosis system for pathogenic bacteria in the treatment of PJI: a prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108982
Enrollment
Unknown
Registered
2025-09-10
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periprosthetic Joint Infection

Interventions

The simple cultivation group :Establish a precise pathogen diagnosis system and implement it according to the precise pathogen diagnosis system.
Pathogen Precision Diagnosis System Group:Establish a precise pathogen diagnosis system and implement it according to the precise pathogen diagnosis system

Sponsors

The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with complete medical records and diagnosed as PJI according to the MSIS standard; 2. Patients voluntarily participated in this study, were physically and mentally capable of tolerating the treatment process and various tests of this study, and agreed to use molecular diagnostic methods to assist in diagnosis. They have signed the informed consent form and have passed the review of the Hospital Ethics Committee of the First Affiliated Hospital of Fujian Medical University.

Exclusion criteria

Exclusion criteria: 1. Those who had chronic inflammation in other parts before the surgery; 2. Patients with complex conditions requiring combined diagnosis of multiple pathogens; 3. Patients who lost follow-up; 4. Those with an expected lifespan of less than half a year.

Design outcomes

Primary

MeasureTime frame
Infection clearance rate in PJI patients;

Secondary

MeasureTime frame
The rate of targeted use of antibiotics;The incidence rate of antibiotic complications;Adverse events related to PJI;The detection rate of pathogenic bacteria and the spectrum of pathogenic microorganisms;The diagnostic efficacy of traditional microbial cultivation and pathogen-specific diagnosis system in PJI;Postoperative joint function score;

Countries

China

Contacts

Public ContactXinyu Fang

First Affiliated Hospital of Fujian Medical University

fangxinyu0417@fjmu.edu.cn+86 180 8476 8503

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026