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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®) used for orthognathic surgery.
Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study.
Investigators : 7 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, who will be treated by orthognathic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty). The bone maturity of the participants (assessed by investigators) need to be sufficient for the treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthognathic surgery using Global D's implants. | Device | Major or minor participants who will be treated by an orthognathic surgery with ORTRAUTEK® or MINITEK® implant(s). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the Global D's implants used for orthognathic surgery, assessed by the Orthognathic Quality of Life Questionnaire (OQLQ) before and after the surgery. | The evolution of patient's quality of life will be assessed by comparing the score of the Orthognathic Quality of Life Questionnaire (OQLQ) before and after the surgery. The OQLQ can vary from 0 (better quality of life) to 88 (worst quality of life). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Security of the Global D implants used for orthognathic surgery - Outcome Measure 1a | Bone consolidation after the surgery, assessed by a correct dental occlusion on the postoperative image. This information is assessed 6 weeks after the surgery: correct occlusion (Yes/No). | 6 weeks after the surgery |
| Security of the Global D implants used for orthognathic surgery - Outcome Measure 1b |
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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 orthognatic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty). The bone maturity of the participants (assessed by investigators) need to be sufficient for the treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Pierre CORRE, MD | Cranio-maxillofacial surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | 44000 | France |
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| ID | Term |
|---|---|
| D019767 | Maxillofacial Abnormalities |
| D008440 | Maxillary Fractures |
| ID | Term |
|---|---|
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D018640 | Stomatognathic System Abnormalities |
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Bone consolidation after the surgery, assessed by the alimentation of the patient. This information is assessed 6 weeks after the surgery: solid alimentation of the patient (Yes/No). |
| 6 weeks after the surgery |
| Security of the Global D implants used for orthognathic surgery - Outcome Measure 2 | Adverse events identification, assessment and follow-up. | 18 months |
| Surgeon satisfaction on the implant's utilisation | 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/ Not very satisfied / Unsatisfied). | Immediately following surgery |
| D009057 | Stomatognathic Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| 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 |
| D014947 | Wounds and Injuries |