Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

Completed

• Conditions: Hallux Valgus

• Registration Number: NCT05523219
• Lead Sponsor: Societe dEtude, de Recherche et de Fabrication

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-15
• Primary Completion: 2022-03-02
• Study Completion: 2022-06-07
• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Results First Submitted: 2022-12-09
• Status Verified: 2023-11
• Results First Submitted QC: 2024-04-29
• Last Update Submitted: 2024-04-29
• Results First Posted: 2024-05-01
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AOFAS Score	3 and 12 months	To confirm the performance of varisation staples in conservative surgery of Hallux Valgus, according to the indications covered by the CE Marking (Akin's osteotomy) and according to the surgeon's current practice investigator.; The scores range from 0 to 100, The average preoperative score was 50 to 60 points. Post-operatively, a score of 80 points is a good post-operative result, with the patient experiencing no or low levels of residual pain and full or partial recovery of joint function. The AOFAS Score is considered excellent between 90 and 100 points, good between 80 and 89, fair between 60 and 79, and poor below 60 points.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	3 and 12 months	The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation
Number of Complications Observed During the Clinical Investigation	12 months	Number of complications observed throughout the clinical investigation

Trial Locations

Locations (1)

Victor Hugo Clinical; 🇫🇷 Paris, Ile De France, France