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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Trauma Injury; Maxillofacial Trauma; Maxilla Fracture
• Intervention / Treatment: Device: Trauma surgery using Global D's implants.

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 102

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE)
  • Lyon, France
    • Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of male and female, major or minor, who will be treated by trauma surgery. The patients will have maxillary, mandibular or maxillomandibular fractures with/without annex skull's or face's fractures.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; 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.	Device: Trauma surgery using Global D's implants.; Major or minor participants who will be treated by an trauma surgery with ORTRAUTEK® or MINITEK/MICROTEK® implant(s).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the Global D's implants used for trauma surgery assessed by the evaluation of the functional jaw activity 6 months after the surgery	The functional jaw activity will be evaluated with the Mandibular Function Impairment Questionnaire (MFIQ) 6 months after the surgery. This questionnaire have 17 items, that have to be answered with a Likert scale from 1 (No problem) to 5 (very hard or impossible).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the Global D implants used for trauma surgery - Outcome Measure 1	Evolution of functional jaw activity, assessed by the evolution of MFIQ questionnaire's answers at 3 timepoints (pre-operative, 4-6 weeks after the surgery and 6 months after the surgery). The post-operatives answers will be compared to the pre-operative answers.	6 months
Security of the Global D implants used for trauma surgery - Outcome Measure 2	Adverse events identification, assessment and follow-up.	1 year
Security of the Global D implants used for trauma surgery - Outcome Measure 3	Bone consolidation after the surgery, 4-6 weeks after the surgery and 6 months after the surgery.	6 months
Performance of the Global D implants used for trauma surgery - Outcome Measure 4	Evolution of the patient's buccal quality of life in preoperative, 4-6 weeks after the surgery and 6 months after the surgery. To assessed this buccal quality of life, the patient will answered to Oral Health Impact Profile (OHIP-14) questionnaire. This questionnaire is composed of 14 questions, the patient can answer from 0 (Never) to 4 (Very Often).	6 months
Surgeon satisfaction on the implant's utilisation - Outcome Measure 5	Assessment by a satisfaction questionnaire, specially developed for the study, completed by the surgeon after the surgery. The surgeon evaluates each item using a likert scale (Highly Satisfied/ Satisfied/ Unsatisfied/Very Unsatisfied)	Immediately following surgery
Localisation and annex fractures data collection	If applicable, localisation and annex fractures data collection, and the medical device's references used to treat thoses fractures.	12 months

Collaborators and Investigators

• Sponsor: Global D
• Investigators: Principal Investigator: Julie Chauvel-Picard, MD, Cranio-maxillofacial surgeon

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Performance; Medical device; Plate; Screw; Cranio-maxillofacial; Trauma surgery; Global D
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Fractures, Bone; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Jaw Fractures; Maxillofacial Injuries; Skull Fractures; Accidental Injuries; Maxillary Fractures
• Other Study ID Numbers: 2102-G-CMF-TRAUMA-R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No