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

NCT05672069 | Completed Results

• 1 other identifier: 2021-08
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Diseases

Outcome Measures

Primary Outcomes (1)

• Reduction of the Patient's Pain and Restoration of Walking

  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 Outcomes (4)

• Survival Rate

  12 months

• Foot Bone Consolidation

  12 months

• Patient Satisfaction

  12 months

• Adverse Event

  Peroperative to 12 months

Interventions

Osteosynthesis PROCEDURE

Foot pathologies

Also known as: Arthrodesis, Osteotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Vulnerable persons
• People with contraindications (including pregnant women)

Sponsors & Collaborators

• Societe dEtude, de Recherche et de Fabrication: lead

Study Sites (1)

Hôpital Privé Saint-Martin

Pessac, 33600, France

Location

MeSH Terms

Conditions

Foot Diseases

Interventions

Fracture Fixation, Internal; Arthrodesis; Osteotomy

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

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.

Results Point of Contact

• Title: Sponsor
• Organization: SERF

clinical@serf.fr

+33 4.72.05.60.10

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: December 7, 2022
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2024-04

Locations

FR (1)