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

NCT05361317 | Active Not Recruiting

• 1 other identifier: 2022-1
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus in terms of functional capacities of patient's foot determined thanks to the "general sub-score" of the European Foot and Ankle Society scale

  Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus in terms of functional capacities of the patient's foot, with the evaluation of the "general sub-score" of the European Foot and Ankle Society (EFAS) questionnaire during post-operative visit at 6 months. The questionnaire collects information on the following categories: functional capacity of the patient's foot in general (6 items), and functional capacity of the patient's foot during sport (4 items). The scores to be calculated range from 0-4 per question, 0-24 for the general category (the only category to be evaluated for the primary outcome). A score of 0 indicates the worst possible foot/ankle symptoms and 24 indicates no symptoms foot/ankle. In this study, an objective score of 16 (out of a total of 24) was determined

  6 months post-operative

Secondary Outcomes (8)

• Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of clinical parameters with the evaluation of the evolution of the pain with Visual Analog Scale

  6-8 weeks, 3-4 months, 6 months and 2 years post-operative

• Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus with evaluation of clinical parameters: evaluation of the evolution of the quality of life with American Orthopedic Foot and Ankle Scale

  3-4 months, 6 months and 2 years post-operative

• Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of clinical parameters : evaluation of the evolution of the quality of life with The Short Form (36) Health Survey

  6 months and 2 years post-operative

• Confirm performance and effectiveness of the device for the correction of hallux valgus with the evaluation of clinical parameters: evaluation of functionality of the foot in sport with "sub-score sport" of the European Foot and Ankle Society scale

  3-4 months, 6 months and 2 years post-operative

• Confirm performance and effectiveness of the device for the correction of hallux valgus with the evaluation of radiographics parameters: evaluation of evolution of angular measures (hallux valgus, Inter-metatarsal and Distal Metaphyseal Articular Angles)

  6-8 weeks, 3-4 months, 6 months and 2 years post-operative

Study Arms (1)

Hallux valgus correction

OTHER

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

Device: Nexis® PECA Bunion device

Interventions

Nexis® PECA Bunion device DEVICE

Hallux valgus correction with percutaneous chevron and Akin osteotomy.

Hallux valgus correction

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novastep: lead

Study Sites (4)

New Clinic Bel Air

Bordeaux, France

Location

Policlinic Bordeaux North Aquitaine

Bordeaux, France

Location

Saint-Charles Clinic

Lyon, France

Location

Toulouse University Hospital

Toulouse, France

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• Loïc Girod

  Novastep

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 4, 2022
• Study Start: June 13, 2022
• Primary Completion: January 15, 2025
• Study Completion (Estimated): June 13, 2026
• Last Updated: March 7, 2025

Record last verified: 2024-06

Locations

FR (4)