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

October 5, 2026 updated by: Global D

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

Completed

Conditions

Intervention / Treatment

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 (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population is composed of male and female, major or minor, who will be treated for trauma surgery. The patients 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

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 for trauma surgery.
Device: Trauma surgery using Global D's implants.

Major or minor participants who will be treated for a 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
Time Frame: 6 months

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
Time Frame: 6 months

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
Time Frame: 6 months

Adverse events identification, assessment and follow-up.
6 months
Security of the Global D implants used for trauma surgery - Outcome Measure 3
Time Frame: 6 months

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
Time Frame: 6 months

Evolution of the patient's buccal quality of life at 3 timepoints: preoperative, 4-6 weeks after the surgery and 6 months after the surgery. The patient will answer the "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
Time Frame: Immediately following surgery

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
Time Frame: 6 months

If applicable, localisation and annex fractures data collection, and the medical device's references used to treat thoses fractures.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Global D

Investigators

  • Principal Investigator: Julie Chauvel-Picard, MD, Cranio-maxillofacial surgeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2023

Primary Completion (Actual)

June 2, 2026

Study Completion (Actual)

June 2, 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 (Actual)

October 7, 2026

Last Update Submitted That Met QC Criteria

October 5, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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