Clinical trial NCT04458961: MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Keywords: Arthropathy
Arthropathy Related to Infection
Arthropathy of Knee Joint
One-stage
Two-stage
Infection
Prosthetic joint infection
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Exeter
name: Nuffield Orthopaedic Centre NHS Trust
name: Nottingham University Hospitals NHS Trust
name: Wrightington, Wigan and Leigh NHS Foundation Trust
First posted: 2020-07-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Ease of recruitment of participants
timeFrame: 20 months
Secondary outcomes:
measure: Explaining the study
timeFrame: 20 months
measure: Reasons for non-participation
timeFrame: 20 months
measure: Patient experience
timeFrame: 2 weeks after surgery
measure: Surgeon experience
timeFrame: 20 months
measure: Protocol adherence
timeFrame: 20 months
measure: Healthcare resource utilisation
timeFrame: 20 months
measure: Comparison of two sites
timeFrame: 20 months
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) outcome and completion rates
timeFrame: 20 months
measure: Oxford Knee Score (OKS) outcome and completion rates
timeFrame: 20 months
measure: EQ-5D-5L outcome and completion rates
timeFrame: 20 months
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter NHS Trust (RD&E NHSFT)
state: Devon
city: Oxford
country: United Kingdom
facility: Nuffiels Orthopaedic Centre (NOC)
Study officials:
affiliation: Royal Devon and Exeter NHS Foundation Trust
name: Andrew Toms, FRCS
role: PRINCIPAL_INVESTIGATOR
References: