About this trial
Participants after first-stage of knee infection reimplantation will be assign to one of two groups: with stem vs. with sleeve. Investigators will check participants on clinical, laboratory and reinfection signs. The main hypothesis is that better mechanical stability of endoprosthesis with sleeves will support infection treatment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
second-stage of knee reimplantation
primary knee replacement in primary knee osteoarthritis
fulfillment of International Consensus Meeting 2018 infection criteria
Disqualifiers
intraoperative bone defects Anderson Orthopedic Research Institute score >II
autoimmune disease
diabetes
peripheral vascular disease
Trial design
Parallel
Treatments tested in this trial
stabilization with stem
DeviceIn both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
stabilization with sleeve
DeviceIn both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
Treatment groups
Trial outcomes
Primary outcomes
Reinfection
Rate of reinfection in both groups
Secondary outcomes
Loosening radiological signs
Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System
Other outcomes
Knee Society Score
Clinical evaluation of patients after knee revision
The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Clinical evaluation of patients after knee revision
Visual Analogue Score
Clinical evaluation of patients after knee revision
Alignment
Radiological alignment of knee after operation in degrees
Sponsors and contacts
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