Maxilla Fracture, Maxillofacial Abnormalities, Orthognathic Surgery
Conditions
Keywords
Orthognathic surgery, Performance, Security, Plates, Screw, Medical device, Cranio-maxillofacial
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®) used for orthognathic surgery.
Detailed description
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.
Interventions
DEVICEOrthognathic surgery using Global D's implants.
Major or minor participants who will be treated by an orthognathic surgery with ORTRAUTEK® or MINITEK® implant(s).
Sponsors
Global D
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or female patient, major or minor, having reached bone maturity according to the judgement of the investigator, * Patient having first orthognathic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty) * Patient who received orthodontic treatment prior to orthognathic surgery. * Patient with abilities to read, understand and answer to the study quality of life questionnaire. * 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) * Person on legal protection * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1 year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Security of the Global D implants used for orthognathic surgery - Outcome Measure 1a | 6 weeks after the surgery | 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). |
| Security of the Global D implants used for orthognathic surgery - Outcome Measure 1b | 6 weeks after the surgery | 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). |
| Security of the Global D implants used for orthognathic surgery - Outcome Measure 2 | 18 months | Adverse events identification, assessment and follow-up. |
| Surgeon satisfaction on the implant's utilisation | 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/ Not very satisfied / Unsatisfied). |
Countries
France
Outcome results
None listed