NCT05284318 Prospective Cohort Study on Antibiotic Course and Efficacy After Two-stage Revision in PJI.
| NCT ID | NCT05284318 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Fujian Medical University |
| Condition | Periprosthetic Joint Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2023-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2021-12-01 with a primary completion date of 2023-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Zhang, Director
STUDY DIRECTOR
First Affiliated Hospital of Fujian Medical University
Frequently Asked Questions
Who can join the NCT05284318 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periprosthetic Joint Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05284318 currently recruiting?
Yes, NCT05284318 is actively recruiting participants. Contact the research team at 9738006@qq.com for enrollment information.
Where is the NCT05284318 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT05284318 clinical trial?
NCT05284318 is sponsored by First Affiliated Hospital of Fujian Medical University. The principal investigator is Zhang, Director at First Affiliated Hospital of Fujian Medical University. The trial plans to enroll 500 participants.