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

NCT05284318 | Recruiting

• 1 other identifier: MRCTA ECFAH of FMU 2021404
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periprosthetic Joint Infection; Anti-Bacterial Agents

Keywords

Periprosthetic joint infection; Second-stage revision; Anti-Bacterial Agents

Outcome Measures

Primary Outcomes (1)

• Clearance rate of infection

  Number of subjects with infection cleared/total number of subjects who completed follow-up

  31, December，2026

Interventions

Antibiotics treatment DRUG

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

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• \- 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.
• \. 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.

You may not qualify if:

• \. Follow-up data not available. 2. Researchers judge that patients no longer meet the standards of the study due to compliance problems

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

Study Officials

• Zhang, Director

  First Affiliated Hospital of Fujian Medical University

  STUDY DIRECTOR

Central Study Contacts

Fang

CONTACT

18084768503; 9738006@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: December 1, 2021
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

CN (1)