At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples
In Brief
An observational study for Hallux Valgus. Completed, enrolled 81 participants across 1 site.
Detailed Summary
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).