At a glance
ClinicalIndex Comparison RecordN/ACompleted· 25 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study for Skull Fractures. Completed, enrolled 25 participants across 1 site.
Detailed 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 Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSkull Fractures
CountriesGermany
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
First PostedNov 2021
Enrollment StartMar 2022
Primary CompletionMar 2023
Study CompletionOct 2023
TodayJul 2026
First PostedNov 15, 2021
Enrollment StartMar 22, 2022
Primary CompletionMar 9, 2023
Study CompletionOct 27, 2023
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 4.6 years ago