Badanie kliniczne: Peri-Prosthetic Joint Infection

Kryteria wyłączenia kto nie może wziąć udziału (19)

1. Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
2. The investigational implant components (femoral and/or acetabular) are not suitable for the patient anatomy or bone defect
3. Patients who require plate osteosynthesis at the implantation site
4. Patients with an already implanted silver-coated device
5. Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy
6. Patients currently undergoing cancer treatment, e.g. chemotherapy or radiation therapy
7. Severe soft tissue defects that require local or free flap procedure
8. Periprosthetic joint infections with evidence of fungal infection
9. Antibiotic suppression therapy
10. BMI > 40 kg/m2
11. Pregnancy, breast-feeding, or women of childbearing potential and not taking adequate contraceptive precautions
12. Known or patient reported hypersensitivity to silver or titanium
13. Patients held in a custodial setting
14. Patients in a relationship of dependence on the sponsor, the clinic or the investigator
15. Patients with contraindication for the investigational and comparator devices:
16. in case of secondary diseases influencing the function of the joint implant
17. in case of severe osteoporosis or osteomalacia
18. in case of poor bone quality and osseous malformations, diseases in the area of the implant fixation, which may primarily or subsequently affect the stability of the joint replacement anchorage
19. in case of non-regenerative bone conditions with lack of proximal femoral bone support and failure of defect union when use of prosthesis heads with neck length XXL is indicated