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Skull Fractures

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

Sponsored by Aesculap AG

About this trial

Last updated 2 years ago

Study ID

AAG-O-H-2043

Status

Active, not recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial 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.

What are the participation requirements?

Yes

Inclusion Criteria

- Written informed consent

- Age ≥ 18 years

- Use of CranioFix®2 system according to IfU

- Planned postoperative MRI within clinical routine

No

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

Locations

Location

Status