Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices
Conditions: Foot Diseases
Sponsor: Societe dEtude, de Recherche et de Fabrication

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Official title :  
Ambispective, Multicentre, Open-label Study Evaluating the Clinical 
Outcomes of Foot Surgery Using SERF Medical Devices 
 
NCT number : NCT05672069 
 
Document date : 10/11/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Title 
Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes 
of Foot Surgery Using SERF Medical Devices 
Sponsor 
SERF  
85 avenue des bruyères  
69150 Décines Charpieu 
France 
Rational (or 
justification) 
The aim of the study is to follow patients with foot pathology. These patients 
undergo foot surgery with the aim of reducing their pain and restoring their ability 
to walk. This study will monitor changes in the patient's quality of life before and 
after the operation.  
The products under investigation are CE marked under Directive 93/42/EEC with 
clinical data based on equivalent devices. Regulation 2017/745 requires the 
collection of clinical data specific to each device. Consequently, this study will 
collect clinical data on the performance and safety of the devices, making it 
possible to confirm the favourable benefit/risk profile for the patient.  
Implants studies 
The devices studied in this clinical trial are as follows:  
- FAST plates (CE marked since 2018) 
- FAST screws (CE marked since 2016) 
- Toe FAST (CE marked since 2021) 
- VEOFIX screws (CE marked since 2019) 
The devices in the FAST screws, FAST plates, Toe FAST and VEOFIX screws ranges 
have been designed to be implanted in patients requiring repair or stabilization of 
elements of the foot, up to and including stabilization and fixation of the bones 
between them. 
Population concerned  
The target population for this study was any adult patient implanted with FAST 
screws, FAST plates, Toe FAST and VEOFIX screws between november 2021 and 
october 2022. 
Subject population 
For each Extremity product, the number of inclusions was set at 80, giving a total 
of 320 subjects for this study.  
The following selection criteria were used.  
 
Inclusion criteria:  
- Male or female subject of legal age at the date of implantation;  
- Subject implanted with one or more implants: FAST Screw, FAST Plate, Toe 
FAST and VEOFIX Screw between November 2021 and October 2022; 
- Subject able to understand the information and instructions given by the 
investigator;  
- Subject with a social security affiliation.  
Exclusion criteria:  
- Vulnerable persons  
- People with contraindications (including pregnant women)  
Non-inclusion criteria:  

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As the series is observational and involves an additional procedure that is neither 
burdensome nor invasive, all implanted patients will be considered. However, the 
following patients will not be included:  
Subjects who have not expressed their consent to the collection of their data and 
participation in the study. 
Methodology 
Post-marketing clinical follow-up study performed according to standard care 
with an additional, non-burdensome, non-invasive procedure (Case 4.1) 
ambispective, multicentre, open-label, non-comparative. Only a quality-of-life 
questionnaire (AOFAS Score) and patient satisfaction will be requested in 
addition to standard care. 
Objectives 
Primary objective:  
- To evaluate the reduction in patient pain and the restoration of walking.  
Secondary objectives: 
- To collect performance and safety data to assess the subject's outcomes 
and functional status. 
Endpoints 
Primary endpoints:  
American Orthopaedic Foot and Ankle Society (AOFAS) score >80 points at 12 
months. This score is assessed using a questionnaire measuring the patient's 
pain, function and mobility of the foot. It incorporates both subjective and 
objective information. Patients report their pain and the doctor assesses bone 
alignment. The scores range from 0, the worst, to 100, the best. There are different 
AOFAS scores depending on the location of the implant: - AOFAS Forefoot - Hallux 
- AOFAS Midfoot - AOFAS Ankle/Hindfoot 
Secondary endpoints:  
- Survival rate of each implants, at 12 months, to determine the Kaplan-
Meier type survival curve, with any revision, whatever the cause, as the 
endpoint. Each inflection point will correspond to a revision surgery 
involving the removal or replacement of a component of the implant in 
question, whatever the cause of the revision. Patients who died or were lost 
to follow-up will be included in the analysis.  
- Bone consolidation rate of the cohort, the evaluation of bone 
consolidation at 12 months is assessed by the investigator via the following 
question: ‘On radiographic reading, is bone consolidation satisfactory? 4 
answers are proposed: ‘total / partial / none / no information’.  
- Overall patient satisfaction will be assessed at 12 months using the 
following question: ‘Given your expectations, are you satisfied with your 
operation? 4 answers are proposed: ‘I am completely satisfied with the 
results of my operation / My condition has not improved as much as I had 
hoped, but I would be prepared to undergo the same operation for the same 
result / The operation has improved my condition, but I would not be 
prepared to undergo the same operation for the same result / My condition 
is the same or even worse than before my operation’.  
- Complications / effects and adverse events during and after the operation 
at all follow-up visits. 

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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.  
Indirectly nominative 
nature of the data  
Data is collected and stored in a pseudo-anonymized format that does not allow 
any patient to be identified through the data collected. Under no circumstances 
will patient names be transmitted or communicated to SERF. 
Ethical consideration 
CIP and associated procedures obtained an EC approbation on 18/11/2022 (CPP 
Nord Ouest III), prior to investigation initiation on 07/12/2022. As per its design, 
the investigation is submitted to an ethic committee and is reported to a 
Competent Authority (ANSM). This study was registered on clinicaltrials.gov 
public database. 
Data quality assurance 
A sponsor’s clinical staff member will monitor collected clinical data through 
source data verification and source data review. A report will then be prepared. 
Study-related 
treatment(s) / 
procedure(s) 
Only a quality-of-life questionnaire and patient satisfaction (an additional 
procedure that is non-burdensome and non-invasive) are required for 
participation in this CI, compared with the standard care provided as part of the 
routine follow-up to foot surgery at each centre.   
Study schedule 
Study preparation: January-June 2022 
Inclusion: as soon as regulatory approvals are obtained, estimated for November 
2022 
End of monitoring: 10/2023 
CI report: Q3 2024 
Study duration 
The total duration of the study (inclusion + follow-up) is 2 years. 
Statistical analysis 
No statistical tests are planned for this CI. Only a descriptive analysis of the data 
is planned.