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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Single Center PMCF-study on the Performance and Safety of the CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures to the Neurocranium

Conditions
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Skull Fractures

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone flap planarity after implantation (Comparison of planarity at two time points) | Rate of patients in which a dislocation of the bone flap occurs (defined as the height of the tilting (depression / protrusion) greater than the bone width | Through postoperative course: at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events during the study | Number of adverse events e.g. foreign body reactions, infections, injury to the dura, injury to the scalp, epiduralhaematoma, wound healing disorders with special focus on (serious) adverse events with (possible) relation to the investigational product | through study completion, an average of 3 months | 
| Handling of CranioFix®2 system | Assessment of handling, documented on a Likert scale 1 to 5 (1 is the best, 5 is the worst result) | intraoperative | 
| Stability of the bone flap after fixation | Assessment of stability of the bone flap intraoperatively and at postoperative follow-up, documented on a Likert scale 1 to 5 | intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months) | 
| Cosmetic outcome | Assessment of cosmetic outcome intraoperatively, at discharge and at post-operative follow-up documented on a 3 point scale (good, fair, bad) | intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Flap Fixation, Fractures to the Neurocranium, Craniotomized bone flaps