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

Skull Fractures Clinical Trial

— CRANFLAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05119595
• Other study ID #: AAG-O-H-2043
• Status: Completed
• Start date: March 22, 2022
• Est. completion date: October 27, 2023

Study information

• Verified date: February 2024
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 27, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Skull Fractures

Locations

Country	Name	City	State
Germany	Klinikum Stuttgart - Katharinenhospital	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)