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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
New Clinic Bel Air
Bordeaux, France
Policlinic Bordeaux North Aquitaine
Bordeaux, France
Saint-Charles Clinic
Lyon, France
Toulouse University Hospital
Toulouse, France
Start Date
June 13, 2022
Primary Completion Date
January 15, 2025
Completion Date
June 13, 2026
Last Updated
March 7, 2025
86
ACTUAL participants
Nexis® PECA Bunion device
DEVICE
Lead Sponsor
Novastep
NCT07267156
NCT05534724
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04716140