Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-11 @ 11:43 PM
Study NCT ID:
NCT02405702
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2015-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Importance of Patient Selection for Treatment of Infected Total Knee Prosthesis
Sponsor:
University Hospital, Strasbourg, France
Organization:
Study Overview
Official Title:
Does the Selection of Patients Helps Healing the Infection After Change in One Step of a Knee Replacement?
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: