An interventional study of stabilization with stem and stabilization with sleeve in Knee Infection, sponsored by Prof A Gruca Teaching Hospital. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by Prof A Gruca Teaching Hospital · Not applicable, Interventional, and Treatment
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.
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.
45 studies on the registry are indexed under Reinfection; 7 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 24 interventional studies indexed under Reinfection.
Browse Reinfection studies →Prof A Gruca Teaching Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group of patients with stem endoprosthesis stabilization
Device: stabilization with stem
Group of patients with sleeve endoprosthesis stabilization
Device: stabilization with sleeve
In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
Reinfection
Rate of reinfection in both groups
Time frame: 2 years
Loosening radiological signs
Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System
Time frame: 2 years
Knee Society Score
Clinical evaluation of patients after knee revision
Time frame: 1 year
The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Clinical evaluation of patients after knee revision
Time frame: 1 year
Visual Analogue Score
Clinical evaluation of patients after knee revision
Time frame: 1 year
Alignment
Radiological alignment of knee after operation in degrees
Time frame: 6 weeks
C-reactive protein
After operation and at period controls (mg/l)
Time frame: 1 year
Erythrocyte sedimentation rate
After operation and at period controls (mm/h)
Time frame: 1 year
Plan to share: Yes — Study protocol and Informed consent form will be shared
Supporting information: Study protocol, Icf
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Prof A Gruca Teaching Hospital