Actively Recruiting
Effect of Antibiotic Treatment Course on Clinical Outcome After Two-stage Revision of Prosthetic Joint Infection: A Prospective Cohort Study
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2022-03-17
500
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter prospective cohort study to evaluate the effects of antibiotic treatment duration on patients undergoing two-stage revision surgery for prosthetic joint infection (PJI). The study focuses on patients diagnosed with PJI based on MSIS criteria who have already received spacer implantation and a full course of antibiotics. The goal is to analyze infection control rates following these treatments and better understand the outcomes after secondary joint revision surgery. Eligible patients receive intravenous antibiotic treatment for 2 weeks after the first stage, followed by decisions on continued antibiotic use by the attending physician, tailored to each patient's condition. The study includes a follow-up period with clinical evaluations at 1, 3, 6, 12, 18, and 24 months after starting antibiotic treatment post-secondary revision. All participants have signed informed consent forms prior to inclusion. During the study, patients undergo regular clinical assessments to monitor infection control and overall health. Researchers will evaluate the primary outcome of infection clearance rate at least 2 years after surgery. The study aims to gather detailed data on the antibiotic treatment course and its relationship with long-term infection control. Participants' progress and response to treatment are closely observed throughout the follow-up period until the study ends in late 2026.
CONDITIONS
Brief Title
Prospective Cohort Study on Antibiotic Course and Efficacy After Two-stage Revision in PJI.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A diagnosis of prosthetic joint infection was made according to MSIS criteria.
- Received spacer implantation and a full course of antibiotic treatment lasting at least 6 weeks.
- Clinically determined to have infection control and underwent secondary joint revision.
- Age 18 years or older.
- Voluntarily agreed to participate, physically and mentally able to tolerate treatment and tests.
- Signed informed consent and passed ethics committee approval.
You will not qualify if you...
- Follow-up data are not available.
- Patient no longer meets study criteria due to compliance issues as judged by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years until study completion
Participants who have undergone secondary joint revision surgery for prosthetic joint infection are observed to evaluate the effect of antibiotic treatment course on clinical outcomes.
Follow-up visits as per routine clinical care; exact number varies
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
Research Team
F
Fang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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