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

Novastep

Status: Enrolling

Conditions: Hallux Valgus

Treatments: Device: Nexis® PECA Bunion device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05361317

2022-1

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

Hallux valgus correction

Other group

Description:

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

Treatment:

Device: Nexis® PECA Bunion device