Trauma InjuryNCT05742932
Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery
An observational study of Trauma Injury and Maxilla Fracture, run by Global D at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Trauma Injury, Maxilla Fracture, Maxillofacial Trauma
- What is being tested?
- Trauma surgery using Global D's implants.
- Type of treatment
- Medical device
- How many people
- 99 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Mar 2023to 2 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
France2 sites
Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE)
Lyon
Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE)
Lyon
About this study
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.
Read the 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.
- Conditions
- Trauma Injury, Maxilla Fracture, Maxillofacial Trauma
- Being tested
- Trauma surgery using Global D's implants.
- Keywords
- Performance, Safety, Screw, Plate, Medical device, Trauma surgery, Cranio-maxillofacial, Global D
- Medical subject headings
- Accidental Injuries, Maxillary Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma surgery using Global D's implants.Device
Major or minor participants who will be treated for a trauma surgery with ORTRAUTEK® or MINITEK/MICROTEK® implant(s).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Trauma surgery using Global D's implants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 6 months
Security of the Global D implants used for trauma surgery - Outcome Measure 2
Adverse events identification, assessment and follow-up.
Measured: 6 months
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.
Measured: 6 months
Performance of the Global D implants used for trauma surgery - Outcome Measure 4
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).
Measured: 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)
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start7 Mar 2023
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie Chauvel-Picard, MD, Principal investigator, Cranio-maxillofacial surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742932
- Sponsor's protocol ID
- 2102-G-CMF-TRAUMA-R
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery
- ClinicalTrials.gov ID
- NCT05742932
- Acronym / sponsor ID
- 2102-G-CMF-TRAUMA-R
- Conditions
- Trauma Injury, Maxilla Fracture, Maxillofacial Trauma
- Keywords
- Performance, Safety, Screw, Plate, Medical device, Trauma surgery, Cranio-maxillofacial, Global D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Global DIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Trauma surgery using Global D's implants.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. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Study group |
Primary outcome
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 secondary outcomes
Performance of the Global D implants used for trauma surgery - Outcome Measure 1
Time frame: 6 months
Security of the Global D implants used for trauma surgery - Outcome Measure 2
Time frame: 6 months
Security of the Global D implants used for trauma surgery - Outcome Measure 3
Time frame: 6 months
Performance of the Global D implants used for trauma surgery - Outcome Measure 4
Time frame: 6 months
Surgeon satisfaction on the implant's utilisation - Outcome Measure 5
Time frame: Immediately following surgery
Localisation and annex fractures data collection
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Chauvel-Picard, MD principal investigator
Cranio-maxillofacial surgeon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Injury and Maxilla Fracture, run by Global D at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.