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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aesculap AG
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Planarity of Bone Flap After Implantation
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- 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))