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
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
New Clinic Bel Air
Bordeaux
Policlinic Bordeaux North Aquitaine
Bordeaux
Saint-Charles Clinic
Lyon
Toulouse University Hospital
Toulouse
Time Frame
Start Date: 2022-06-13
Completion Date: 2026-06-13
Participants
Target number of participants: 86
Treatments
Other: Hallux valgus correction
Hallux valgus correction for all patients : intervention during intraoperative visit, with Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
Related Therapeutic Areas
Sponsors
Leads: Novastep

This content was sourced from clinicaltrials.gov