Trials / Active Not Recruiting
Active Not RecruitingNCT05361317
Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device : Evaluation of Quality of Life Scores, Angular Correction, Bone Consolidation and Occurrence of Adverse Events
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Novastep · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Nexis® PECA Bunion device | Hallux valgus correction with percutaneous chevron and Akin osteotomy. |
Timeline
- Start date
- 2022-06-13
- Primary completion
- 2025-01-15
- Completion
- 2026-06-13
- First posted
- 2022-05-04
- Last updated
- 2025-03-07
Locations
4 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05361317. Inclusion in this directory is not an endorsement.