This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage). Therefore, its objectives were as follows:
- To assess functional clinical score's evolution,
- To evaluate patient's satisfaction
- To confirm safety of varisation staples The target population for this study was any adult patient implanted with VEOFIX varisation staples in their intended uses between 15/02/2021 and 15/05/2021.
Patients were implanted and followed as per standard of care led in the investigational site.
The following regulation and guidelines were followed for this investigation:
- Standard ISO 14155:2020 "Good Clinical Practice"undirectly applicable;
- Regulation (UE) 2016/679 (RGPD) ;
- Regulation (UE) 2017/745 (MDR) ;
- MEDDEV 2.12.1;
- Local regulation (loi " jardé ", loi " informatique et libertés "). As per its design, the investigation is considered as involving human beings, and therefore require submission to an ethic committee or declaration to a Competent Authority (ANSM) and CPP. This study was registered on CPP (CPP Ile de France VII).