Knee Infection
Conditions
Keywords
knee arthroplasty, infection, two-stage, sleeve, stem
Brief summary
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.
Detailed description
All participants will be treated because of periprosthetic joint infection of the knee, after primary arthroplasty. All participants will be treated with two-stage protocol. In first stage debridement and spacer implantation will be performed. After 6-week antibiotics, when will be absent clinical or laboratory signs of reinfection, second stage will be performed. All participants upon fulfillment all inclusion and exclusion criteria will sign informed consent. With computer software patients will be randomized to one of two groups: with stem vs. with sleeve. After operation all patients will get target antibiotics for 3 weeks. Pre-operation and after on periodic controls will checked the Knee Society Score, The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC), Visual Analogue Scale. After 2-year observation evaluation of reinfection rate will be performed in both groups.
Interventions
DEVICEstabilization with stem
In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
DEVICEstabilization with sleeve
In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
Sponsors
Prof A Gruca Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Two groups with endoprosthesis stabilisation with stem or sleeve.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* second-stage of knee reimplantation * primary knee replacement in primary knee osteoarthritis * fulfillment of International Consensus Meeting 2018 infection criteria
Exclusion criteria
* intraoperative bone defects Anderson Orthopedic Research Institute score \>II * autoimmune disease * diabetes * peripheral vascular disease * congenital or acquired immunodeficiencies * lack of pathogens after first-stage * multi-bacterial infection * multidirectional instability * lack of patient consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reinfection | 2 years | Rate of reinfection in both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Loosening radiological signs | 2 years | Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System |
Other
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Score | 1 year | Clinical evaluation of patients after knee revision |
| Alignment | 6 weeks | Radiological alignment of knee after operation in degrees |
| Knee Society Score | 1 year | Clinical evaluation of patients after knee revision |
| Erythrocyte sedimentation rate | 1 year | After operation and at period controls (mm/h) |
| C-reactive protein | 1 year | After operation and at period controls (mg/l) |
| The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) | 1 year | Clinical evaluation of patients after knee revision |
Countries
Poland
Contacts
Primary ContactPaweł Bartosz
Outcome results
None listed