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

Launched by GLOBAL D · Feb 15, 2023

Keywords

ClinConnect Summary

This clinical trial, called CMF-TRAUMA, is evaluating the safety and effectiveness of specific implants used in surgery for facial injuries, particularly fractures in the jaw and face. The implants being studied are known as Global D implants (ORTRAUTEK® and MINITEK/MICROTEK®). The goal is to ensure these devices work well and are safe for patients undergoing their first surgery for facial trauma.

To participate in this study, you need to be at least 11 years old and have sustained a facial injury that requires surgery. It’s important that you can read and respond to questions about the study. However, if you have allergies to any of the implant materials, have certain infections, or are pregnant or breastfeeding, you won't be eligible to join. If you decide to participate, you’ll be asked to complete some questionnaires and will receive medical care related to your injury. This study is currently recruiting volunteers, and your involvement could contribute to important research in improving treatments for facial trauma.

Gender

ALL

Eligibility criteria

• 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