Importance of Patient Selection for Treatment of Infected Total Knee Prosthesis

NCT ID: NCT02405702

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-01

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

restrospective study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Yves JENNY, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Strasbourg, France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

007-14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Topical Vancomycin for Infection Prophylaxis in TJA
NCT04993027 NOT_YET_RECRUITING PHASE2