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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05271383
Other study ID # 2101-G-CMF-ORTHO-R
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 4, 2022
Est. completion date January 2025

Study information

Verified date July 2023
Source Global D
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 198
Est. completion date January 2025
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
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).

Locations

Country Name City State
France CHU de Nantes Nantes

Sponsors (1)

Lead Sponsor Collaborator
Global D

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Security of the Global D implants used for orthognathic surgery - Outcome Measure 2 Adverse events identification, assessment and follow-up. 18 months
Secondary 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
Secondary 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
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