N/A N=25

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

Skull Fractures

Bottom Line

View on ClinicalTrials.gov: NCT05119595 ↗

Enrolled (actual)

Serious AEs

8.0%

Results posted

May 2025

Primary outcome: Primary: Planarity of Bone Flap After Implantation — 23; 0; 2; 17 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aesculap AG
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Planarity of Bone Flap After Implantation	23; 0; 2; 17; 0; 8	—
SECONDARY Number of Participants With Adverse Events (Intra- and Postoperative)	3	—
SECONDARY Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale	12; 12; 1; 0; 0	—
SECONDARY Stability of the Bone Flap After Fixation	19; 5; 1; 0; 15; 8	—
SECONDARY Cosmetic Outcome	24; 1; 0; 0; 23; 0	—

Summary

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05119595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.