CompletedNot Applicable

MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence

United Kingdom3 participantsStarted 2020-11-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ease of recruitment of participants

Timeframe: 20 months

Trial details

NCT IDNCT04458961

SponsorRoyal Devon and Exeter NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-30

View on ClinicalTrials.gov More Arthroplasty, Replacement, Knee trials