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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma surgery using Global D's implants. | Device | Major or minor participants who will be treated by an trauma surgery with ORTRAUTEK® or MINITEK/MICROTEK® implant(s). |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Julie Chauvel-Picard, MD | Cranio-maxillofacial surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE) | Lyon | France | ||||
| Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE) |
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| 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 |
| Lyon |
| France |
| ID | Term |
|---|---|
| D000081084 | Accidental Injuries |
| D008440 | Maxillary Fractures |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
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