NCT Number: NCT02405702
Importance of Patient Selection for Treatment of Infected Total Knee Prosthesis
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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
Sponsors and collaborators
Lead sponsor
University Hospital, Strasbourg, France
Other
Registry information
Official study title
Does the Selection of Patients Helps Healing the Infection After Change in One Step of a Knee Replacement?
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Apr 1, 2015
- Registry last updated
- Sep 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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