NCT05271383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2024

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

February 18, 2022

Last Update Submit

January 13, 2026

Conditions

Orthognathic SurgeryMaxillofacial AbnormalitiesMaxilla Fracture

Keywords

Orthognathic surgeryPerformanceSecurityPlatesScrewMedical deviceCranio-maxillofacial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Security of the Global D implants used for orthognathic surgery - Outcome Measure 1a

    6 weeks after the surgery

  • Security of the Global D implants used for orthognathic surgery - Outcome Measure 1b

    6 weeks after the surgery

  • Security of the Global D implants used for orthognathic surgery - Outcome Measure 2

    18 months

  • Surgeon satisfaction on the implant's utilisation

    Immediately following surgery

Study Arms (1)

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.

Device: Orthognathic surgery using Global D's implants.

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).

Study group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is composed of male and female, major or minor, who will be treated by orthognatic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty). The bone maturity of the participants (assessed by investigators) need to be sufficient for the treatment.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, 44000, France

Location

MeSH Terms

Conditions

Maxillofacial AbnormalitiesMaxillary Fractures

Condition Hierarchy (Ancestors)

Craniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesStomatognathic System AbnormalitiesStomatognathic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesJaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Study Officials

  • Pierre CORRE, MD

    Cranio-maxillofacial surgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 9, 2022

Study Start

February 4, 2022

Primary Completion

August 2, 2024

Study Completion

August 2, 2024

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations

FR(1)