MIKROBE

• Research type

  Research Study

• Full title

  Management of Infected Knee Replacements-Obtaining Best Evidence (MIKROBE) A feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infection

• IRAS ID

  272334

• Contact name

  Alison Kerridge

• Contact email

  alison.kerridge@nhs.net

• Sponsor organisation

  RD+E NHSFT

• Duration of Study in the UK

  2 years, 6 months, 1 days

• Research summary

  Research Summary
  Total knee replacement (TKR) surgery is common, with over 100,000 operations performed in the UK in 2015. After surgery, about 1% patients develop a deep infection in their replaced knee. Left untreated, this infection can cause severe pain and disability. There are two types of operations that can be performed to treat the infection:
  • a one-stage revision involves one operation to remove the joint, clean the infected area and then implanting a new joint immediately
  • a two-stage revision involves two operations: the joint is removed in one operation, a temporary spacer device is inserted, the infection is treated with antibiotics for a number of months, and a new joint is implanted in a second operation.
  Both treatments are widely used and are good at treating infection but we don’t know which has the best long-term outcomes for patients. In the future we would like to run a project to find out which is better for patients-a ‘randomised controlled trial’. In that, we would then compare outcomes, such as pain and mobility, between the two groups to see which operation is better.
  Before we run the larger future project, we are doing this small study to see if patients and surgeons are keen to take part in this type of project and to investigate our research methods. We anticipate 40 patients with infected TKR will take part. Half will be randomly chosen to receive the one-stage operation and half will receive the two-stage operation. We will talk to surgeons and patients both before and after surgery about their thoughts on this project and on the subject of one or two stage surgery. The findings from this study will help us to know if it will be possible to run a much larger study to find out which operation is better for patients.

  Summary of Results
  The results will imminently be submitted for publication and will be made public following the dissemination plan once published.

• REC name

  Wales REC 4

• REC reference

  19/WA/0326

• Date of REC Opinion

  13 Nov 2019

• REC opinion

  Favourable Opinion