Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.

Conditions
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Knee Infection

Intervention / Treatment
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* Device: stabilization with stem
* Device: stabilization with sleeve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups with endoprosthesis stabilisation with stem or sleeve.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stem stabilization<br>Group of patients with stem endoprosthesis stabilization | Device: stabilization with stem<br>* In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.<br>|
| Active Comparator: Sleeve stabilization<br>Group of patients with sleeve endoprosthesis stabilization | Device: stabilization with sleeve<br>* In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reinfection | Rate of reinfection in both groups | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loosening radiological signs | Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee arthroplasty, infection, two-stage, sleeve, stem