Evaluating Global D implants for trauma surgery
Prospective Study to Evaluate the Performance (by the Assessment of Patient's Mandibular Function) and the Safety of Global D's Implants of Cranio-maxillofacial Surgery Indicated for Trauma Surgery (CMF-TRAUMA)
This study is testing how safe and effective Global D implants are for patients having their first surgery for facial injuries from trauma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 102 (estimated) |
| Ages | 11 Years and up |
| Sex | All |
| Sponsor | Global D Industry-sponsored |
| Locations | 2 sites (Lyon and 1 other locations) |
| Trial ID | NCT05742932 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance and safety of Global D implants used in trauma surgery for maxillofacial injuries. It is a non-interventional, prospective, multicentric, national, open-label, and non-comparative study conducted across at least six sites in France. The study will involve patients undergoing their first facial trauma surgery and will collect data to statistically evaluate the effectiveness and safety of the implants.
Who should consider this trial
Good fit: Ideal candidates include patients aged 11 and older undergoing their first facial trauma surgery involving maxillary or mandibular fractures.
Not a fit: Patients with allergies to implant components, infections, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of surgical treatments for patients with facial trauma.
How similar studies have performed: While this study follows established regulatory frameworks, the specific use of Global D implants in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lyon and 1 other locations
- Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE) — Lyon, France (Recruiting)
- Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE) — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Julie Chauvel-Picard, MD — Cranio-maxillofacial surgeon
- Study coordinator: Victor DOLIGEZ
- Email: v.doligez@globald.com
- Phone: +33 (0)6 24 17 39 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.