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

Orthognathic Surgery Clinical Trial

— CMF-ORTHO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05271383
• Other study ID #: 2101-G-CMF-ORTHO-R
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Maxillofacial Abnormalities
• Orthognathic Surgery

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