Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

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).

Inclusion Criteria:

• Man or woman
• Major patient on the date of surgery
• Patient with foot pathology requiring Akin osteotomy
• Patient not opposed to the collection of data

Exclusion Criteria:

• Patient unable to understand and follow the postoperative instructions
• Patient with a contraindication to the use of the implant
• Non-implanted patient with a varisation staple