PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
Launched by AESCULAP AG · Nov 2, 2021
Trial Information
Current as of June 28, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Written informed consent
- • Age ≥ 18 years
- • Use of CranioFix®2 system according to IfU
- • Planned postoperative MRI within clinical routine
- Exclusion Criteria:
- • Pregnancy
- • Patients with hypersensitivity to metals or allergies to the implant materials
- • Inflammations in the region of the implant site
- • Bone conditions that rule out the application of CranioFix®2 titanium clamps
- • Use with artificial cranial bone flaps
- • Bone tumors in the area supporting the implant
- • Degenerative bone diseases
- • Missing dura mater
- • Application in the facial skull (viscerocranium) and in the orbital or skull-base region
- • Combination of implant components from different manufacturers, i.e. additional use of plates and screws on the same bone fragment
About Aesculap Ag
Aesculap AG is a prominent global medical device manufacturer specializing in surgical instruments, implants, and innovative healthcare solutions. With a rich history rooted in excellence and innovation, Aesculap AG is dedicated to advancing surgical practices through cutting-edge technology and a commitment to improving patient outcomes. The company collaborates with healthcare professionals and institutions to conduct clinical trials that evaluate the safety and efficacy of its products, ensuring that they meet the highest standards of quality and performance. Through its rigorous research and development initiatives, Aesculap AG aims to contribute significantly to the field of medicine and enhance the standards of surgical care worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stuttgart, , Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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