N/A
Completed N=25
PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
Skull Fractures
Source: ClinicalTrials.gov NCT05119595 ↗
Enrolled (actual)
25
Serious AEs
8.0%
Results posted
May 2025
Primary outcomePrimary: Planarity of Bone Flap After Implantation — 23; 0; 2; 17 Participants
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.
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 | — |
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
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. Informational only — not medical advice.