NCT02405702

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2016

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

January 25, 2015

Last Update Submit

September 4, 2025

Conditions

Keywords

InfectionKneeknee replacement

Outcome Measures

Primary Outcomes (1)

  • Recovery from the infection measured visually

    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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infections

Study Officials

  • Jean-Yves JENNY, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2015

First Posted

April 1, 2015

Study Start

March 1, 2015

Primary Completion

January 31, 2016

Study Completion

January 31, 2016

Last Updated

September 5, 2025

Record last verified: 2025-09