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

NCT05119595 | Completed Results

• 1 other identifier: AAG-O-H-2043
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Skull Fractures

Keywords

Bone Flap Fixation; Fractures to the Neurocranium; Craniotomized bone flaps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With Adverse Events (Intra- and Postoperative)

  through study completion, an average of 3 months

• Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale

  intraoperative

• 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)

• Cosmetic Outcome

  intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Written informed consent
• Age ≥ 18 years
• Use of CranioFix®2 system according to IfU
• Planned postoperative MRI within clinical routine

You may not qualify if:

• 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

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (1)

Klinikum Stuttgart - Katharinenhospital

Stuttgart, 70174, Germany

Location

MeSH Terms

Conditions

Skull Fractures

Condition Hierarchy (Ancestors)

Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Fractures, Bone; Wounds and Injuries

Results Point of Contact

• Title: Diana Kupferschmid, Study Manager of B. Braun
• Organization: B.Braun Aesculap

studies@aesculap.de

0049746195

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 15, 2021
• Study Start: March 22, 2022
• Primary Completion: March 9, 2023
• Study Completion: October 27, 2023
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-05

Locations

DE (1)