PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures (CRANFLAP)

Aesculap

Status: Completed

Conditions: Skull Fractures

Study type: Observational

Funder types: Industry

Identifiers

NCT05119595

AAG-O-H-2043

Details and patient eligibility

About

The CranioFix®2 PMCF study has been set up as an action within the framework of a proactive post-market surveillance system of the manufacturer. The aim of this observational study is to collect systematically and proactively data regarding the performance of CranioFix®2, like adverse events (AEs), handling and cosmetic outcome, under daily clinical practice when used as intended by the manufacturer.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design