Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Foot Diseases
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Reduction of the Patient's Pain and Restoration of Walking
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Survival Rate(12 months)
- Foot Bone Consolidation(12 months)
- Patient Satisfaction(12 months)
- Adverse Event(Peroperative to 12 months)