Informations générales (source: ClinicalTrials.gov)
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)
Observational
Global D (Voir sur ClinicalTrials)
mars 2023
décembre 2025
05 avril 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE) - Lyon - France | Mathieu Daurade, MD | Contact (sur clinicalTrials) | |||
| Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE) - Lyon - France | Julie Chauvel-Picard, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Male or female patient, major or minor (11 years old minimum)
- Patient having first facial trauma surgery (maxillary, mandibular or
maxillomandibular fractures with/without annex skull's or face's fractures)
- Patient with abilities to read, understand and answer to the study questionnaires.
- Patient (and his legal representative if minor) who signed the study consent form.
- Patient affiliated to a social security system.
- Male or female patient, major or minor (11 years old minimum)
- Patient having first facial trauma surgery (maxillary, mandibular or
maxillomandibular fractures with/without annex skull's or face's fractures)
- Patient with abilities to read, understand and answer to the study questionnaires.
- Patient (and his legal representative if minor) who signed the study consent form.
- Patient affiliated to a social security system.
- Patient allergic to one of the components of the implants
- Patient with physical or mental inabilities that will compromise the follow-up
during the study
- Patient with acute or chronic infection (local or systemic)
- Patients with bone's tumors in the anchorage area of the implant
- Person on legal protection
- Pregnant or breastfeeding women