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

Global D

Status: Completed

Conditions: Maxillofacial Abnormalities; Maxilla Fracture; Orthognathic Surgery

Treatments: Device: Orthognathic surgery using Global D's implants.

Study type: Observational

Funder types: Industry

Identifiers

NCT05271383

2101-G-CMF-ORTHO-R

Details and patient eligibility

About

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®) used for orthognathic surgery.

Full 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 in order to determine the performance and the security of those devices.

Enrollment: 198 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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)
• Person on legal protection
• Pregnant or breastfeeding women

Trial design

198 participants in 1 patient group

Study group

Description:

Male and female, major or minor, who will be treated by orthognathic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty). The bone maturity of the participants (assessed by investigators) need to be sufficient for the treatment.

Treatment:

Device: Orthognathic surgery using Global D's implants.