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Study Evaluating the Performance and Safety of Global D Implants Indicated for Trauma Surgery (CMF-TRAUMA)

Trauma Injury Clinical Trial

Official title:
Prospective Study to Evaluate the Performance (by the Assessment of Patient's Mandibular Function) and the Safety of Global D's Implants of Cranio-maxillofacial Surgery Indicated for Trauma Surgery (CMF-TRAUMA)

Clinical Trial 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.

Clinical Trial Description

Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study. Investigators : at least 6 sites in France. A statistical evaluation will be performed on those data in order to determine the performance and the security of those devices. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05742932
Study type Observational
Source Global D
Contact Nathalie TRETOUT
Phone +33478569700
Email n.tretout@globald.com
Status Recruiting
Phase
Start date March 7, 2023
Completion date December 2025
View Details
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