Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-15

Study Completion Date

2022-06-07

Brief Summary

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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).

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Detailed Description

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Conditions

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Hallux Valgus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No