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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-13

Study Completion Date

2026-06-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Hallux Valgus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Hallux valgus correction

Hallux valgus correction for all patients : intervention during intraoperative visit, with Nexis® PECA Bunion Implantable Osteosynthesis Medical Device

Group Type OTHER

Nexis® PECA Bunion device

Intervention Type DEVICE

Hallux valgus correction with percutaneous chevron and Akin osteotomy.

Interventions

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Nexis® PECA Bunion device

Hallux valgus correction with percutaneous chevron and Akin osteotomy.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient with a hallux valgus foot pathology requiring correction
* First line operation
* Use of the medical device concerned PECA Bunion
* Unilateral operation
* Patient aged 18 or over
* Isolated hallux valgus correction, without associated surgical procedures
* Patient able to respect the prescriptions and recommendations of his surgeon
* Patient able to read and understand the information note on the objectives of the study and the collection of their data
* Patient able to sign a consent form

Exclusion Criteria

* Patient with a contraindication to the device under investigation,
* Simultaneous participation in another clinical investigation protocol,
* Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, pregnant or breastfeeding women, minors.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No