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

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Planarity of Bone Flap After Implantation	Through postoperative course: at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months after surgery)	The primary variable was the planarity of the bone flap after implantation. The bone flap planarity was evaluated as the rate of patients in which a dislocation of the bone flap occurred - defined as the height of the tilting (depression / protrusion) greater than the bone width.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (Intra- and Postoperative)	through study completion, an average of 3 months	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
Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale	intraoperative	Assessment of handling, documented on a Likert scale 1 to 5 (1 is the very good, 2 is good, 3 is acceptable, 4 is poor, 5 is very poor)
Stability of the Bone Flap After Fixation	intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months)	Assessment of stability of the bone flap, documented on a Likert scale 1 to 5 (1≙very good, 2≙good, 3≙medium, 4≙poor, 5≙very poor)
Cosmetic Outcome	intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months)	Assessment of cosmetic outcome intraoperatively, at discharge and at post-operative follow-up documented on a 3 point scale (good, fair, bad)