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

Global D198 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

198

Conditions

Orthognathic Surgery Maxillofacial Abnormalities Maxilla Fracture

Interventions

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).

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

CHU de Nantes

Nantes, France

Outcomes

Primary Outcomes

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).

Time frame: 1 year

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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.

Time frame: 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).

Time frame: Immediately following surgery

Data from ClinicalTrials.gov

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