Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Study to Evaluate the Performance (by the Assessment of Patient's Quality of Life) and the Safety of Global D's Implants of Cranio-maxillofacial Surgery Indicated for Orthognathic Surgery

Conditions
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Orthognathic Surgery, Maxillofacial Abnormalities, Maxilla Fracture

Intervention / Treatment
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* Device: Orthognathic surgery using Global D's implants.


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>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. | Device: Orthognathic surgery using Global D's implants.<br>* Major or minor participants who will be treated by an orthognathic surgery with ORTRAUTEK® or MINITEK® implant(s).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 
| Security of the Global D implants used for orthognathic surgery - Outcome Measure 3 | Bone stability after the surgery. This criteria will be assessed by comparing bones' 3D localisation right after the surgery and at the end of the patient's follow up, according to a specific bone stability measurement protocol that will permits to standardize all measurements. | 12 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthognathic surgery, Performance, Security, Plates, Screw, Medical device, Cranio-maxillofacial