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

Status

Completed

Conditions

Intervention / Treatment

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.

Sponsor

University Hospital, Strasbourg, France

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.

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