Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-01 @ 2:10 PM
Study NCT ID:
NCT04458961
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2020-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence
Sponsor:
Royal Devon and Exeter NHS Foundation Trust
Organization:
Study Overview
Official Title:
MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence A Feasibility Study for a Randomised Controlled Trial of One-stage or Two-stage Surgery for Prosthetic Knee Infection
Status:
COMPLETED
Status Verified Date:
2023-11
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:
MIKROBE
Brief Summary:
Following a prosthetic knee joint infection, two types of operative approach can be undertaken to treat the infection: a one-stage or two-stage revision operation. Both approaches are widely used and are good at treating infection but we don't know which has the best long-term outcomes for patients. This trial aims to assess the feasibility of conducting a randomised controlled trial to evaluate whether treating a prosthetic knee infection with one-stage revision surgery gives a better outcome than two-stage revision surgery in terms of patient function and pain, and cost-effectiveness.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: