NCT05742932

Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery (CMF-TRAUMA)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 102 (estimated)
• Sponsor: Global D · Industry
• Sex: All
• Age: 11 Years
• 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/MICROTEK®) used for trauma surgery.

Detailed description

Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study. Investigators : 5 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

• Trauma Injury
• Maxilla Fracture
• Maxillofacial Trauma

Interventions

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

Timeline

• Start date: 2023-03-07
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2023-02-24
• Last updated: 2026-01-14

Locations

2 sites across 1 country: France