NCT04458961: MIKROBE

MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence

Completed NA Last updated 18 November 2023

What this trial tests

NA trial testing One-stage in Arthroplasty, Replacement, Knee in 3 participants. Completed in 30 January 2023.

Timeline

17 November 2020

Primary endpoint
30 January 2023

30 January 2023

Quick facts

Lead sponsor	Royal Devon and Exeter NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	17 November 2020
Primary completion	30 January 2023
Estimated completion	30 January 2023
Sites	2 locations across United Kingdom

Drugs / interventions tested

• One-stage
• Two-stage

Conditions studied

• Arthroplasty, Replacement, Knee — all drugs for Arthroplasty, Replacement, Knee →

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Who can join

18 and older, any sex, with Arthroplasty, Replacement, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. MIKROBE: a feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infection.
   Terry R, Dean S, Hourigan P, Waterson HB, et al · · 2025 · PMID 40241215 · DOI 10.1186/s40814-025-01634-4