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).

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Key information

Conditions

Hallux Valgus Foot Deformities Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Victor Hugo Clinical

Paris, Île-de-France Region, 75, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

AOFAS Score

Time frame: 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 outcomes

Patient Satisfaction

Time frame: 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

Time frame: 12 months

Number of complications observed throughout the clinical investigation

Sponsors and collaborators

Lead sponsor

Societe dEtude, de Recherche et de Fabrication

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Aug 31, 2022
Registry last updated: May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed