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

Completed

• Conditions: Maxilla Fracture; Orthognathic Surgery; Maxillofacial Abnormalities
• Interventions: Device: Orthognathic surgery using Global D's implants.

• Registration Number: NCT05271383
• Lead Sponsor: Global D

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.

Study Timeline

• Study Start: 2022-02-04
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-09
• Primary Completion: 2024-08-02
• Study Completion: 2024-08-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Orthognathic surgery using Global D's implants.	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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 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 3	12 months	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.
Security of the Global D implants used for orthognathic surgery - Outcome Measure 2	18 months	Adverse events identification, assessment and follow-up.

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France