- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405702
Importance of Patient Selection for Treatment of Infected Total Knee Prosthesis
September 4, 2025 updated by: University Hospital, Strasbourg, France
Does the Selection of Patients Helps Healing the Infection After Change in One Step of a Knee Replacement?
The infection of a total knee replacement often imposes changing implants.
The change in two step is currently considered the gold standard.
The change in one step is a much debated attitude: strictly contra-indicated for some professionals, but others agree to reserve these for favorable suspected cases selected.
Several criteria have been proposed in the literature: age, condition, duration of infection, known bacterium responsible, not virulent and sensitive to antibiotics, no fistula, no significant bone destruction.
But these criteria are poorly validated, standing over an experience of surgical teams rather than high-level scientific studies.
Some authors have proposed to achieve change in one step systematically.
The results of these cohorts on healing the infection does not seem very different from the changes in two steps.
But it is most often single-center series, uncontrolled, with small numbers.
Study Overview
Study Type
Observational
Enrollment (Actual)
60
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients over 18 years having surgery for the management of knee infection after change in one step of a knee replacement prothesis in the participating services between 2000 and 2010.
Description
Inclusion Criteria:
- Patients over 18 years
- Patient having surgery for the management of knee infection after change in one step of a knee replacement prothesis in the participating services between 2000 and 2010.
Exclusion Criteria:
- Patients under 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recovery from the infection measured visually
Time Frame: for the duration of hospital stay, up to 1 year
|
show that the selection process of patients used improve treatment outcomes of infection in total knee replacement
|
for the duration of hospital stay, up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jean-Yves JENNY, MD, University Hospital, Strasbourg, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2015
Primary Completion (Actual)
January 31, 2016
Study Completion (Actual)
January 31, 2016
Study Registration Dates
First Submitted
January 25, 2015
First Submitted That Met QC Criteria
March 28, 2015
First Posted (Estimated)
April 1, 2015
Study Record Updates
Last Update Posted (Estimated)
September 5, 2025
Last Update Submitted That Met QC Criteria
September 4, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 007-14
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.