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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem stabilization | Active Comparator | Group of patients with stem endoprosthesis stabilization |
|
| Sleeve stabilization | Active Comparator | Group of patients with sleeve endoprosthesis stabilization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stabilization with stem | Device | In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reinfection | Rate of reinfection in both groups | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Loosening radiological signs | Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score | Clinical evaluation of patients after knee revision | 1 year |
| The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) | Clinical evaluation of patients after knee revision |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paweł Bartosz | Contact | +48 793629685 | pbartosz@vp.pl |
| Name | Affiliation | Role |
|---|---|---|
| Paweł Bartosz | Prof. A. Gruca Teaching Hospital in Otwock | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gruca Teaching Hospital, Centre of Postgraduate Medical Centre | Recruiting | Otwock | Masovian Voivodeship | 05-400 | Poland |
Study protocol and Informed consent form will be shared
1 year
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017348 | Microscopy, Electron, Scanning Transmission |
| ID | Term |
|---|---|
| D046529 | Microscopy, Electron, Transmission |
| D008854 | Microscopy, Electron |
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
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Two groups with endoprosthesis stabilisation with stem or sleeve.
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| stabilization with sleeve | Device | In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization. |
|
| 1 year |
| Visual Analogue Score | Clinical evaluation of patients after knee revision | 1 year |
| Alignment | Radiological alignment of knee after operation in degrees | 6 weeks |
| C-reactive protein | After operation and at period controls (mg/l) | 1 year |
| Erythrocyte sedimentation rate | After operation and at period controls (mm/h) | 1 year |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |