Gruca Teaching Hospital, Centre of Postgraduate Medical Centre
Otwock, Masovian Voivodeship, 05-400, Poland
Location status: Recruiting
NCT Number: NCT04446676
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Otwock, Masovian Voivodeship, 05-400, Poland
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2 years
Rate of reinfection in both groups
Time frame: 2 years
Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System
Time frame: 1 year
Clinical evaluation of patients after knee revision
Time frame: 1 year
Clinical evaluation of patients after knee revision
Time frame: 1 year
Clinical evaluation of patients after knee revision
Time frame: 6 weeks
Radiological alignment of knee after operation in degrees
Time frame: 1 year
After operation and at period controls (mg/l)
Time frame: 1 year
After operation and at period controls (mm/h)
Contact information is provided by the study sponsor or research team.
Prof A Gruca Teaching Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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