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

Foot Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05672069
• Other study ID #: 2021-08
• Status: Completed
• Start date: December 7, 2022
• Est. completion date: December 13, 2023

Study information

• Verified date: April 2024
• Source: Societe dEtude, de Recherche et de Fabrication
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 13, 2023
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• Vulnerable persons

• People with contraindications (including pregnant women)

Related Conditions & MeSH terms

• Foot Diseases

Intervention

Procedure:
• Osteosynthesis
Foot pathologies

Locations

Country	Name	City	State
France	Hôpital Privé Saint-Martin	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
Societe dEtude, de Recherche et de Fabrication

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Adverse event	Type and occurrence of adverse events	Peroperative to 12 months