Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Stem stabilization Group of patients with stem endoprosthesis stabilization |
Device: stabilization with stem
In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
|
| Active Comparator: Sleeve stabilization 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.
|
Outcome Measures
Primary Outcome Measures
- Reinfection [2 years]
Rate of reinfection in both groups
Secondary Outcome Measures
- Loosening radiological signs [2 years]
Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System
Other Outcome Measures
- Knee Society Score [1 year]
Clinical evaluation of patients after knee revision
- The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) [1 year]
Clinical evaluation of patients after knee revision
- Visual Analogue Score [1 year]
Clinical evaluation of patients after knee revision
- Alignment [6 weeks]
Radiological alignment of knee after operation in degrees
- C-reactive protein [1 year]
After operation and at period controls (mg/l)
- Erythrocyte sedimentation rate [1 year]
After operation and at period controls (mm/h)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gruca Teaching Hospital, Centre of Postgraduate Medical Centre | Otwock | Mazowieckie | Poland | 05-400 |
Sponsors and Collaborators
- Prof A Gruca Teaching Hospital
Investigators
- Principal Investigator: Paweł Bartosz, Prof. A. Gruca Teaching Hospital in Otwock
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Gruca Teaching Hospital