Skull FracturesCRANFLAPNCT05119595

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

An observational study of Skull Fractures, run by Aesculap AG at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Skull Fractures
How many people: 25 participants
Where: 1 siteGermany
Study dates: 22 Mar 2022to 27 Oct 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Klinikum Stuttgart - Katharinenhospital
Stuttgart, 70174

Other trials in Germany

About this study

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

Conditions: Skull Fractures
Keywords: Bone Flap Fixation, Fractures to the Neurocranium, Craniotomized bone flaps
Medical subject headings: Skull Fractures

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 202227 Oct 2023

First posted15 Nov 2021
Study start22 Mar 2022
Primary completion9 Mar 2023
Study completion27 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Skull FracturesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05119595
Sponsor's protocol ID: AAG-O-H-2043
Acronym: CRANFLAP
Status last verified: May 2025
First submitted: 7 Oct 2021
Last updated: 13 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Recruiting
Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
Orbital Fractures, Unilateral
Recruiting
Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates
Mandibular Fractures
Not yet recruiting
Virtual Surgical Planning and Preoperative Plate Bending for Maxillofacial Fractures
Mandibular Fractures, Maxillofacial Injuries
Not yet recruitingObservational study
Epidemiological and Statistical Study of Facial Traumatic Fractures at Assiut University Trauma Hospital
Facial Fractures, Maxillofacial Injuries

All Skull Fractures trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05119595
Acronym / sponsor ID: CRANFLAP / AAG-O-H-2043
Conditions: Skull Fractures
Keywords: Bone Flap Fixation, Fractures to the Neurocranium, Craniotomized bone flaps
Study type: Observational
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Aesculap AGIndustry (pharma, biotech, devices)
Study start: 22 Mar 2022 (actual)
Primary completion: 9 Mar 2023 (actual)
Study completion: 27 Oct 2023 (actual)
First posted: 15 Nov 2021 (actual)
Results: Posted 13 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients enrolled will be prospectively examined according to the study plan until follow-up examination (depending on routine in clinic).

Key inclusion criteria (4 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Planarity of Bone Flap After Implantation
Time frame: 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.

4 secondary outcomes

Number of Participants With Adverse Events (Intra- and Postoperative)
Time frame: through study completion, an average of 3 months
Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale
Time frame: intraoperative
Stability of the Bone Flap After Fixation
Time frame: intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months)
Cosmetic Outcome
Time frame: intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months)

Results and safety

Results posted to the registry on 13 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Observational Study Group	25	17

Primary outcome: Planarity of Bone Flap After Implantation

Time frame: Through postoperative course: at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months after surgery). Count of participants. Unit: Participants

Measure	Observational Study Group n = 25
at discharge (about up to 2 weeks after surgery): yes	23
at discharge (about up to 2 weeks after surgery): no	0
at discharge (about up to 2 weeks after surgery): could not be evaluated	2
post-operative follow-up (3±2 months after surgery): yes	17
post-operative follow-up (3±2 months after surgery): no	0
post-operative follow-up (3±2 months after surgery): could not be evaluated	8

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 ± 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observational Study Group	2 of 25 (8%)	1 of 25 (4%)	1 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Skull Fractures

Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Recruiting
Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
Orbital Fractures, Unilateral
Recruiting
Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates
Mandibular Fractures
Not yet recruiting
Virtual Surgical Planning and Preoperative Plate Bending for Maxillofacial Fractures
Mandibular Fractures, Maxillofacial Injuries
Not yet recruitingObservational study
Epidemiological and Statistical Study of Facial Traumatic Fractures at Assiut University Trauma Hospital
Facial Fractures, Maxillofacial Injuries

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Skull Fractures, run by Aesculap AG at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Planarity of Bone Flap After Implantation (time frame: Through postoperative course: at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months after surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05119595.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.