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NCT Number: NCT05284318

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location status: Recruiting

Location contact

Fang, Vice directors

CONTACT

[email protected]

About this study

Inclusion criteria

  • A diagnosis of PJI was made according to MSIS criteria
  • 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
  • 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

  • Follow up data were not available;
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

Antibiotics treatment

Drug

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

Primary outcomes

  1. Clearance rate of infection

    Time frame: 31, December,2026

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

Study contacts

Contact information is provided by the study sponsor or research team.

Fang

CONTACT

[email protected]

18084768503 ext. 86

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

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

Acronym: PACER-PJI

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Mar 17, 2022
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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