Overview
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.
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.
Eligibility
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.
Exclusion Criteria:
- 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