This study aims to collect real-world clinical data to gather information on the performance and safety of the TriOSS® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation, targeting submission to the new Medical Device Regulation (EU) 2017/745.
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Primary Performance Endpoint
Timeframe: moment after surgery; 6 months; 12 months; 23 months.
Safety Endpoint
Timeframe: moment after surgery; 6 months; 12 months; 23 months.