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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-04

Study Completion Date

2024-08-02

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.

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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.

Conditions

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Orthognathic Surgery Maxillofacial Abnormalities Maxilla Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Orthognathic surgery using Global D's implants.

Intervention Type DEVICE

Major or minor participants who will be treated by an orthognathic surgery with ORTRAUTEK® or MINITEK® implant(s).

Interventions

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Orthognathic surgery using Global D's implants.

Major or minor participants who will be treated by an orthognathic surgery with ORTRAUTEK® or MINITEK® implant(s).

Intervention Type DEVICE

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No