Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices

Study Overview
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Brief Summary
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This clinical investigation was led as a post-marketing clinical follow-up study conducted as part of standard care with an additional, non-invasive, non-invasive procedure (Case 4.1) ambispective, multicentre, open-label, non-comparative. The primary objective of this study is to evaluate the reduction in patient pain and the restoration of walking. The study will also collect performance and safety data to assess the subject's outcomes and functional status. 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. The investigation will be conducted in accordance with the investigation protocol, the laws and regulations (including the Medical regulations (including the Medical Devices Regulation 2017/745) and the ISO 14155:2020, as well as in accordance with the ethical principles described in the Declaration of Helsinki. The collection of personal data will also be compliant with RGPD 2016/679.

Official Title
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Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices

Conditions
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Foot Diseases

Intervention / Treatment
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* Procedure: Osteosynthesis


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Osteosynthesis|Foot pathologies|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the patient's pain and restoration of walking | The information will be collected through 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Determination of the Kaplan-Meier type survival curve, with any revision as the endpoint whatever the cause. At each inflection point, a revision surgery with removal or revision surgery with removal or change of a component of the implant under consideration All causes of revision are considered. Patients who have died or been lost to follow-up will be included in the analysis. | 12 months | 
| Bone consolidation | The information will be collected through investigator's question : on radiographic reading, is the bone consolidation satisfactory? : 4 answers are proposed: total / partial / null / no information. | 12 months | 
| Patient satisfaction | The information will be collected through patient's question : Considering your expectations, are you satisfied with your operation? 4 answers are proposed: I am completely satisfied with the results of my operation results of my operation / My condition has not improved as much as I had hoped, but I but I would be willing to have the same operation for the same result / The operation improved my condition, but I would not be prepared to have the same operation for the same result / My condition is the same or worse than before my operation than before my operation. | 12 months | 
| Adverse event | Type and occurrence of adverse events | Peroperative to 12 months |