Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples
Conditions: Hallux Valgus
Sponsor: Societe dEtude, de Recherche et de Fabrication

 
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Official title :  
Prospective Observational Study for the Evaluation of VEOFIX 
Varisation Staples 
 
 
NCT number : NCT05523219 
 
 
Document date : 17/12/2020 
 
 
 
 
 
 

 
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Title of study 
Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples 
Methodology 
Monocentric prospective observational study of a continuous exhaustive longitudinal 
patient series. 
Sponsor 
SERF 
85 avenue des Bruyères 
69150 Décines-Charpieu 
+33 4.72.05.60.10 
Rational (or 
justification) 
Based on a clinical evaluation that concluded that the benefit/risk balance was 
acceptable but using clinical data from equivalent medical devices in the literature, we 
felt it was necessary to collect our own data in order to confirm the performance and 
safety of VEOFIX staples. 
Implants studied 
Varisation staples (class IIb) from the VEOFIX® range with 4 types of staples 
according to 2 criteria: angulation and entraxe. 
Objectives of the 
study 
The primary objective of this study is to confirm the efficacy of the varisation staples, in 
the indications covered by the CE mark (Akin osteotomy) and in current practice. 
Secondary objectives are to evaluate patient satisfaction and implant safety. 
Population 
concerned 
Selection criteria 
and consent 
In order to reflect current practice, all patients requiring varus osteotomy of the first 
phalanx of the big toe (known as Akin's procedure) may be included in the study.  
These patients should have been informed about their participation in the study and the 
personal data collected prior to their surgery. 
Primary endpoint 
The primary endpoint is the evaluation of the effectiveness of the implant, the chosen 
endpoint is the evolution of the AOFAS score between the pre-operative and post-
operative state.   
Secondary 
endpoints 
The secondary evaluation criteria are: 
- Patient satisfaction rate  
- The safety of the implant through the occurrence of adverse events and adverse 
effects related to the medical device 
Data collected 
The data collected for this study are: demographics, surgery details, clinical scores 
(AOFAS score, patient satisfaction), possible adverse events related or not to the 
implant. 
Data collection and 
transmission 
procedures 
Information will be collected using an Electronic Case Report Form (eCRF) from the 
source data of each patient included in this study. All relevant data from the clinical 
follow-up will be recorded, both clinical data and data on possible adverse events.  
The follow-up modalities correspond to the investigator's current practice, but the 
investigator is invited to inform the study at each patient follow-up at 3 months and 12 
months. The data are recorded directly on an electronic observation book completed by 
the investigator directly or by any other person authorised by the investigator. 
Indirectly 
nominative nature of 
the data 
In order to preserve patient anonymity, patients will be identified by their eCRF 
identification number and matricule. 
A correspondence list is kept in the investigating centre. 
Study duration 
The duration of patient inclusion is 3 months, the maximum expected duration of patient 
follow-up is 12 months. Thus, the study will last a maximum of 15 months from the first 
inclusion. 
Numbers 
The expected number of patients in the registry is estimated to be 100, reflecting the 
average number of patients included consecutively over a quarter.