- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07232771
Reinfection and Re-revision Rates of Periprosthetic Knee Infection Under Four Different Surgical Strategies
Reinfection and Re-revision Rates of Periprosthetic Knee Infection Under Four Different Surgical Strategies: a Single Centre Retrospective Observational Study
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Fujian
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Fuzhou, Fujian, China, 350005
- The First Affiliated Hospital of Fujian Medical University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
According to the inclusion criteria, 145 patients who underwent DAIR, phase 1 revision, phase 1.5 revision, and phase 2 revision surgery for TKA-PJI at the institution between 2012 and 2022 were selected. All patients have completed at least 2 years of follow-up. Follow up includes prosthesis loosening, infection recurrence rate, infection recurrence rate, infection new incidence rate, bacterial positive culture rate, infection free survival rate, and revision rate for any reason.
Sampling Method
Description
Inclusion Criteria
- Patients who met the diagnostic criteria for TKA-PJI;
- Patients who underwent one of the following surgical interventions: DAIR, one-stage revision, 1.5-stage revision, or two-stage revision;
- Patients with complete medical records available;
- Patients who provided informed consent to participate in the study.
Exclusion Criteria:
- Incomplete medical records;
- Poor follow-up compliance, including inability to complete scheduled follow-up visits or refusal to participate in follow-up;
- Follow-up duration less than 2 years.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
DAIR group
DAIR revision involves washout, thorough debridement, antibiotics, and all components of implant retention, but polyethylene exchange
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1-stage revision group
One-stage revision involves open debridement of the infected knee, followed by immediate revision by removal and or reimplantation of all components
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1.5-stage revision group
The 1.5-stage revision involves the use of a functional, articulating antibiotic-loaded knee spacer intended for long-term retention-either indefinitely or until loosening necessitates definitive TKA revision.
We standardize the terminology for this procedure as "1.5-stage revision", as it represents an intermediate strategy between one-stage and two-stage revision for the treatment of PJI following TKA
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2-stage revision group
Two-stage revision, with removal of implants, placement of an antibiotic spacer, and parenteral antibiotic treatment followed by TKA reimplantation has been proposed as the "gold standard" for chronic PJI treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Re-revision rate
Time Frame: 5 year after surgery
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Re-revisions with implant exchange
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5 year after surgery
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Reinfection rate
Time Frame: 2 and 5 year after surgery
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Reinfection rate
|
2 and 5 year after surgery
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Infection-free survival rate
Time Frame: 2 and 5 year after surgery
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Infection-free survival rate
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2 and 5 year after surgery
|
|
All-cause revision rates
Time Frame: 5 year after surgery
|
All-cause revision rates
|
5 year after surgery
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Collaborators and Investigators
Investigators
- Study Director: Liu Zhang, First Affiliated Hospital of Fujian Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTCA,ECFAH of FMU[2019]296
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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