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

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

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.

Study Overview

• Status: Completed
• Conditions: Skull Fractures

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany, 70174
    • Klinikum Stuttgart - Katharinenhospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients enrolled will be prospectively examined according to the study plan until follow-up examination (depending on routine in clinic).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Planarity of Bone Flap After Implantation	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.	Through postoperative course: at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (Intra- and Postoperative)	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
Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale	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)	intraoperative
Stability of the Bone Flap After Fixation	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)	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)

Collaborators and Investigators

• Sponsor: Aesculap AG

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Actual): March 9, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Bone Flap Fixation; Fractures to the Neurocranium; Craniotomized bone flaps
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Fractures, Bone; Skull Fractures
• Other Study ID Numbers: AAG-O-H-2043

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No