Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

NCT05523219 | Completed Results

• 1 other identifier: Veofix varisation staples
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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).

Conditions

Hallux Valgus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Satisfaction

  3 and 12 months

• Number of Complications Observed During the Clinical Investigation

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Due to its non-comparative design, no patient was randomized. Every patient who respected the selection criteria were included to create an exhaustive and consecutive cohort

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Societe dEtude, de Recherche et de Fabrication: lead

Study Sites (1)

Victor Hugo Clinical

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

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Limitations and Caveats

The 12 months follow-up was done in consultation, but when the patient could not move, it was done by telephone. There is a delay in follow-ups for 12 months due to school holidays.

Results Point of Contact

• Title: Sponsor
• Organization: SERF

clinical@serf.fr

+33 4.72.05.60.10

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: February 15, 2021
• Primary Completion: March 2, 2022
• Study Completion: June 7, 2022
• Last Updated: May 1, 2024
• Results First Posted: May 1, 2024

Record last verified: 2023-11

Locations

FR (1)