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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05523219
• Other study ID #: Veofix varisation staples
• Status: Completed
• Start date: February 15, 2021
• Est. completion date: June 7, 2022

Study information

• Verified date: November 2023
• Source: Societe dEtude, de Recherche et de Fabrication
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 7, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hallux Valgus

Locations

Country	Name	City	State
France	Victor Hugo Clinical	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Societe dEtude, de Recherche et de Fabrication

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AOFAS Score	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.	3 and 12 months
Secondary	Patient Satisfaction	The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation	3 and 12 months
Secondary	Number of Complications Observed During the Clinical Investigation	Number of complications observed throughout the clinical investigation	12 months