Status:
COMPLETED
Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
Lead Sponsor:
Global D
Conditions:
Orthognathic Surgery
Maxillofacial Abnormalities
Eligibility:
All Genders
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- Male or female patient, major or minor, having reached bone maturity according to the judgement of the investigator,
- Patient having first orthognathic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty)
- Patient who received orthodontic treatment prior to orthognathic surgery.
- Patient with abilities to read, understand and answer to the study quality of life questionnaire.
- Patient (and his legal representative if minor) who signed the study consent form.
- Patient affiliated to a social security system.
Exclusion
- 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)
- Person on legal protection
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
February 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 2 2024
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT05271383
Start Date
February 4 2022
End Date
August 2 2024
Last Update
July 16 2025
Active Locations (1)
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1
CHU de Nantes
Nantes, France, 44000