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

• Osteosynthesis (Procedure), also known as Arthrodesis, Osteotomy: Foot pathologies

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 18 Years to any

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)

Participant flow

Outcome results

• Reduction of the Patient's Pain and Restoration of Walking (Primary), Mean, points: Total Cohort 42.46 +/- 15.25
• Survival Rate (Secondary), Number, percentage of implant survivorship: Total Cohort 89.3
• Foot Bone Consolidation (Secondary), Number, Number of foot: Total Cohort 124
• Patient Satisfaction (Secondary), Number, Number of foot: Total Cohort 103
• Adverse Event (Secondary), Number, Number of foot: Total Cohort 8

Adverse events

Time frame: 12 months

Serious adverse events by term

Other adverse events by term

Limitations and caveats: This investigation had planned to collect 320 patients (40 per surgeon). However, the amount of data collected for FAST plates (and associated screws), VEOFIX screws and Toe FAST is limited due to a lack of inclusion or an overestimation of the capacity of the investigation.

• Study Protocol (PDF, 2022-11-10)