MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
3 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Amy McAndrew, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal