Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery (CMF-TRAUMA)

Global D

Status: Active, not recruiting

Conditions: Trauma Injury; Maxillofacial Trauma; Maxilla Fracture

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05742932

2102-G-CMF-TRAUMA-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/MICROTEK®) used for trauma surgery.

Full description

Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study.

Investigators : 5 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: 102 estimated patients

Sex: All

Ages: 11+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patient, major or minor (11 years old minimum)
• Patient undergoing surgery on the mandible and/or maxilla (mandatory), with or without associated facial fractures (orbit, upper two-thirds of the face, skull)
• 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

Trial design

102 participants in 1 patient group

Study group

Description:

Male and female, major or minor patients. The patients have maxillary, mandibular, maxillomandibular fracture with/without annex face or skull fracture, and will be treated by trauma surgery.

Treatment:

Device: Trauma surgery using Global D's implants.