N/A
Completed N=81
Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples
Source: ClinicalTrials.gov NCT05523219 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: AOFAS Score — 41.2; 77.0; 88.1 points
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AOFAS Score |
41.2; 77.0; 88.1 | — |
| SECONDARY Patient Satisfaction |
17; 56; 5; 0; 43; 28 | — |
| SECONDARY Number of Complications Observed During the Clinical Investigation |
4; 1; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05523219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.