Clinical trial NCT05271383: Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthognathic Surgery
Maxillofacial Abnormalities
Maxilla Fracture
Keywords: Orthognathic surgery
Performance
Security
Plates
Screw
Medical device
Cranio-maxillofacial
Lead sponsor: Global D
Sponsor class: INDUSTRY
First posted: 2022-03-09
Enrollment: 198
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: Security of the Global D implants used for orthognathic surgery - Outcome Measure 1a
timeFrame: 6 weeks after the surgery
measure: Security of the Global D implants used for orthognathic surgery - Outcome Measure 1b
timeFrame: 6 weeks after the surgery
measure: Security of the Global D implants used for orthognathic surgery - Outcome Measure 2
timeFrame: 18 months
measure: Security of the Global D implants used for orthognathic surgery - Outcome Measure 3
timeFrame: 12 months
measure: Surgeon satisfaction on the implant's utilisation
timeFrame: Immediately following surgery
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Cranio-maxillofacial surgeon
name: Pierre CORRE, MD
role: PRINCIPAL_INVESTIGATOR
References: