Evaluating antibiotic treatment after joint revision surgery for infection
Effect of Antibiotic Treatment Course on Clinical Outcome After Two-stage Revision of Prosthetic Joint Infection: A Prospective Cohort Study.
First Affiliated Hospital of Fujian Medical University · NCT05284318
This study is testing if a specific antibiotic treatment after joint revision surgery for infection can help patients recover better and prevent further infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Fujian Medical University (other) |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT05284318 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective cohort study aims to assess the efficacy of antibiotic treatment following two-stage revision surgery for periprosthetic joint infection (PJI). Eligible patients, diagnosed with PJI and having undergone spacer implantation, will receive a tailored antibiotic regimen based on their clinical evaluation after the second stage of surgery. Participants will be monitored at multiple time points over a two-year period to evaluate infection control rates and treatment outcomes. The study seeks to provide insights into optimal antibiotic courses for managing PJI post-revision surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with PJI and have undergone spacer implantation followed by secondary joint revision.
Not a fit: Patients who do not have follow-up data available or those who do not comply with study requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients suffering from periprosthetic joint infections.
How similar studies have performed: While similar studies have explored antibiotic treatments for PJI, this specific approach focusing on two-stage revision surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fuzhou, Fujian
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (RECRUITING)
Study contacts
- Study coordinator: Fang
- Email: 9738006@qq.com
- Phone: 18084768503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Periprosthetic Joint Infection, Anti-Bacterial Agents, Periprosthetic joint infection, Second-stage revision