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Completed

NCT Number: NCT05119595

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Stuttgart - Katharinenhospital

Stuttgart, 70174, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 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

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

    Time frame: 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)

  3. 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)

    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)

  4. Cosmetic Outcome

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study 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

Acronym: CRANFLAP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2021
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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