NCT05271383

Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery

Prospective Study to Evaluate the Performance (by the Assessment of Patient's Quality of Life) and the Safety of Global D's Implants of Cranio-maxillofacial Surgery Indicated for Orthognathic Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 198 (actual)
• Sponsor: Global D · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for orthognathic surgery.

Detailed description

Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study. Investigators : 7 sites in France. A statistical evaluation will be performed on those data in order to determine the performance and the security of those devices.

Conditions

• Orthognathic Surgery
• Maxillofacial Abnormalities
• Maxilla Fracture

Interventions

Type	Name	Description
DEVICE	Orthognathic surgery using Global D's implants.	Major or minor participants who will be treated by an orthognathic surgery with ORTRAUTEK® or MINITEK® implant(s).

Timeline

• Start date: 2022-02-04
• Primary completion: 2024-08-02
• Completion: 2024-08-02
• First posted: 2022-03-09
• Last updated: 2026-01-14

Locations

1 site across 1 country: France