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

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Reduction of the Patient's Pain and Restoration of Walking	12 months	The information will be collected through AOFAS (American Orthopaedic Foot and Ankle Society) score (\>80 points) at 12 months. This score is assessed using a questionnaire measuring the patient's pain, function and alignment of the foot. This score range from 0 (worst score) to 100 (best score). The score is interpreted as follows : Between 90-100 points : excellent results Between 80-89 points : good results Between 60-79 points : fair results Less than 60 points : poor results This score is composed of 3 sub-scores : (i) Pain score is ranging from 0 to 40 points ; Function score is ranging from 0 to 45 points ; Alignment is ranging from 0 to 15 points.

Secondary Outcome Measures

Name	Time	Method
Survival Rate	12 months	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.
Foot Bone Consolidation	12 months	The information will be collected through investigator's question : "on radiographic reading, is the foot bone consolidation satisfactory? : 4 answers are proposed: "total / partial / null / no information".
Patient Satisfaction	12 months	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".
Adverse Event	Peroperative to 12 months	Type and occurrence of adverse events