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MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence

NCT04458961 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

  • Arthroplasty, Replacement, Knee

Interventions

PROCEDURE

One-stage

A one-stage revision operation involves one operation to remove the joint, thoroughly cleaning the infected area and then implanting a new joint immediately.

PROCEDURE

Two-stage

A two-stage revision operation involves two operations: the joint is removed in one operation, a temporary spacer device is inserted, then the infection is treated with antibiotics, and then a new joint is implanted in a second operation.

Sponsors & Collaborators

  • University of Exeter

    collaborator OTHER

  • Nuffield Orthopaedic Centre NHS Trust

    collaborator OTHER

  • Nottingham University Hospitals NHS Trust

    collaborator OTHER

  • Wrightington, Wigan and Leigh NHS Foundation Trust

    collaborator OTHER

  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Andrew Toms, FRCS · Royal Devon and Exeter NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2023-01-30
Completion
2023-01-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04458961 on ClinicalTrials.gov