Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

Hallux Valgus Clinical Trial

Official title: Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Hallux Valgus

• NCT number: NCT05523219
• Study type: Observational
• Source: Societe dEtude, de Recherche et de Fabrication
• Status: Completed
• Start date: February 15, 2021
• Completion date: June 7, 2022