Status:
ACTIVE_NOT_RECRUITING
Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
Lead Sponsor:
Novastep
Conditions:
Hallux Valgus
Eligibility:
All Genders
18+ years
Phase:
NA
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 performa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2026
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05361317
Start Date
June 13 2022
End Date
June 13 2026
Last Update
March 7 2025
Active Locations (4)
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1
New Clinic Bel Air
Bordeaux, France
2
Policlinic Bordeaux North Aquitaine
Bordeaux, France
3
Saint-Charles Clinic
Lyon, France
4
Toulouse University Hospital
Toulouse, France