Clinical trial NCT05742932: Study Evaluating the Performance and Safety of Global D Implants Indicated for Trauma Surgery (CMF-TRAUMA)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trauma Injury
Maxilla Fracture
Maxillofacial Trauma
Keywords: Performance
Safety
Screw
Plate
Medical device
Trauma surgery
Cranio-maxillofacial
Global D
Lead sponsor: Global D
Sponsor class: INDUSTRY
First posted: 2023-02-24
Enrollment: 102
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Detailed description: Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study.

Investigators : at least 6 sites in France.

A statistical evaluation will be performed on those data in order to determine the performance and the security of those devices.

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

Primary outcomes:
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
timeFrame: 6 months
Secondary outcomes:
measure: Performance of the Global D implants used for trauma surgery - Outcome Measure 1
timeFrame: 6 months
measure: Security of the Global D implants used for trauma surgery - Outcome Measure 2
timeFrame: 1 year
measure: Security of the Global D implants used for trauma surgery - Outcome Measure 3
timeFrame: 6 months
measure: Performance of the Global D implants used for trauma surgery - Outcome Measure 4
timeFrame: 6 months
measure: Surgeon satisfaction on the implant's utilisation - Outcome Measure 5
timeFrame: Immediately following surgery
measure: Localisation and annex fractures data collection
timeFrame: 12 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE)
city: Lyon
country: France
facility: Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE)
Study officials:
affiliation: Cranio-maxillofacial surgeon
name: Julie Chauvel-Picard, MD
role: PRINCIPAL_INVESTIGATOR
References: