Performance and Safety of the Innofix® Screw (IF25)

Exclusion Criteria

• •The patient has got a displaced fracture or an unstable fracture justifying conventional surgical fixation
• •The patient is a pregnant woman or considered getting pregnant during its investigation participation
• •The patient presents medical conditions that could have an impact on the clinical investigation (under responsibility of the investigator)
• •The patient has got one or more contraindications to general anaesthesia
• •The patient has got an insufficient bone strength (severe osteoporosis, local infection, or tumor osteolysis) precluding a correct and long-term fixation
• •The use of the InnoFix® screw can interfere with anatomical structures or physiological performances
• •The patient has got an insufficient tissue coverage at the surgical site
• •The patient has got a sepsis, fever, subcutaneous or cutaneous infection on the implantation way, deep abscess in contact with the fracture site
• •The patient has got a mental or neuromuscular disorder that may cause fixation failure or postoperative complications
• •The patient is allergic and/or hypersensitive to a component of the InnoFix® modules, of the InnoTool™ instruments and to the used cement
• •The patient has got a haemostasis disorder ((INR \>1.5, platelets \<50x109/L)
• •The patient participates to another clinical investigation
• •The patient's life expectancy is lower than 6 months
• •The patient is under guardianship, curatorship or legal protection
• •The patient is deprived of liberty by a judicial or administrative decision