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Completed

NCT Number: NCT05271383

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

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.

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Key information

Conditions

Orthognathic Surgery Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniocerebral Trauma Craniofacial Abnormalities Facial Injuries Fractures, Bone Jaw Fractures Maxilla Fracture Maxillary Fractures Maxillofacial Abnormalities Maxillofacial Injuries Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Skull Fractures Stomatognathic Diseases Stomatognathic System Abnormalities Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, 44000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

    Time frame: 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 outcomes

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 18 months

    Adverse events identification, assessment and follow-up.

  4. Surgeon satisfaction on the implant's utilisation

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Global D

Industry

Registry information

Official study 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

Acronym: CMF-ORTHO

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 9, 2022
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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