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

N/ACompletedNCT05119595

Aesculap AG25 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Skull Fractures

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinikum Stuttgart - Katharinenhospital

Stuttgart, Germany

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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

Time frame: 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)

Time frame: 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)

Time frame: 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)

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

Data from ClinicalTrials.gov

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