MedTrace Logo

Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device

NCT05361317 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-03-07

No results posted yet for this study

Summary

The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices.

The primary objective of the study is to confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation functional capacities of the patient's foot. It will be assessed with "general sub-score" of the EFAS questionnaire determined during the postoperative visit at 6 months.

The evaluation of quality of life scores, angular correction, bone consolidation and occurrence of adverse events will also be carried out.

Conditions

  • Hallux Valgus

Interventions

DEVICE

Nexis® PECA Bunion device

Hallux valgus correction with percutaneous chevron and Akin osteotomy.

Sponsors & Collaborators

  • Novastep

    lead INDUSTRY

Principal Investigators

  • Loïc Girod · Novastep

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2025-01-15
Completion
2026-06-13

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05361317 on ClinicalTrials.gov