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

November 22, 2024 updated by: Societe dEtude, de Recherche et de Fabrication

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.

Study Overview

Status

Completed

Conditions

Foot Diseases

Intervention / Treatment

Procedure: Osteosynthesis

Study Type

Observational

Enrollment (Actual)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Pessac, France, 33600
    - Hôpital privé Saint-Martin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Men or women of legal age, for whom one of the devices is implanted according to the instructions for use. These patients will be monitored according to standard care. As the series is observational and has an additional procedure that is neither burdensome nor invasive, all implanted patients will be considered.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of the Patient's Pain and Restoration of Walking Time Frame: 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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Rate Time Frame: 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.	12 months
Foot Bone Consolidation Time Frame: 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".	12 months
Patient Satisfaction Time Frame: 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".	12 months
Adverse Event Time Frame: Peroperative to 12 months	Type and occurrence of adverse events	Peroperative to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Societe dEtude, de Recherche et de Fabrication

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2022

Primary Completion (Actual)

December 13, 2023

Study Completion (Actual)

December 13, 2023

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria