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

Royal Devon and Exeter NHS Foundation Trust2 sites in 1 country3 target enrollmentNovember 17, 2020

ConditionsArthroplasty, Replacement, Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Royal Devon and Exeter NHS Foundation Trust
Enrollment: 3
Locations: 2
Primary Endpoint: Ease of recruitment of participants
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 17, 2020

End Date

January 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults with prosthetic knee infection suitable for either one-stage or two-stage revision surgery
•Intra-operatively, all cases must have adequate soft-tissue coverage post debridement to allow single or two stage revision surgery.
•Case meets the International Consensus Meeting criteria for infection
•Patients having had a Debridement, Anti-biotic and Implant Retained procedure previously or washout/biopsy only of an infected TKR are suitable

Exclusion Criteria

•Unable or unwilling to undergo either treatment
•Lacking capacity to consent to research
•Refusal to consent to study for any reason
•Re-revision of prosthetic knee infection if first revision was for infection
•Presence of tuberculosis infection

Outcomes

Primary Outcomes

Ease of recruitment of participants

Time Frame: 20 months

Number of recruits compared to the number of potential participants.

Secondary Outcomes

Comparison of two sites(20 months)
Explaining the study(20 months)
Surgeon experience(20 months)
Protocol adherence(20 months)
Reasons for non-participation(20 months)
Knee injury and Osteoarthritis Outcome Score (KOOS) outcome and completion rates(20 months)
Oxford Knee Score (OKS) outcome and completion rates(20 months)
EQ-5D-5L outcome and completion rates(20 months)
Patient experience(2 weeks after surgery)
Healthcare resource utilisation(20 months)