Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05742932

Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery (CMF-TRAUMA)

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/MICROTEK®) used for trauma surgery.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Trauma Injury Accidental Injuries Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Maxilla Fracture Maxillary Fractures Maxillofacial Injuries Maxillofacial Trauma Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

11 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Femme Mère Enfant - Hospices Civils de Lyon (FRANCE), Lyon, France

Loading trial locations.

About this study

Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study.

Investigators : 5 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 (11 years old minimum)
  • Patient undergoing surgery on the mandible and/or maxilla (mandatory), with or without associated facial fractures (orbit, upper two-thirds of the face, skull)
  • Patient with abilities to read, understand and answer to the study questionnaires.
  • 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)
  • Patients with bone's tumors in the anchorage area of the implant
  • Person on legal protection
  • Pregnant or breastfeeding women

Treatment and study plan

Trauma surgery using Global D's implants.

Device

Major or minor participants who will be treated by an trauma surgery with ORTRAUTEK® or MINITEK/MICROTEK® implant(s).

Primary outcomes

  1. Performance of the Global D's implants used for trauma surgery assessed by the evaluation of the functional jaw activity 6 months after the surgery

    Time frame: 6 months

    The functional jaw activity will be evaluated with the Mandibular Function Impairment Questionnaire (MFIQ) 6 months after the surgery. This questionnaire have 17 items, that have to be answered with a Likert scale from 1 (No problem) to 5 (very hard or impossible).

Secondary outcomes

  1. Performance of the Global D implants used for trauma surgery - Outcome Measure 1

    Time frame: 6 months

    Evolution of functional jaw activity, assessed by the evolution of MFIQ questionnaire's answers at 3 timepoints (pre-operative, 4-6 weeks after the surgery and 6 months after the surgery). The post-operatives answers will be compared to the pre-operative answers.

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

    Time frame: 1 year

    Adverse events identification, assessment and follow-up.

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

    Time frame: 6 months

    Bone consolidation after the surgery, 4-6 weeks after the surgery and 6 months after the surgery.

  4. Performance of the Global D implants used for trauma surgery - Outcome Measure 4

    Time frame: 6 months

    Evolution of the patient's buccal quality of life in preoperative, 4-6 weeks after the surgery and 6 months after the surgery. To assessed this buccal quality of life, the patient will answered to Oral Health Impact Profile (OHIP-14) questionnaire. This questionnaire is composed of 14 questions, the patient can answer from 0 (Never) to 4 (Very Often).

  5. Surgeon satisfaction on the implant's utilisation - Outcome Measure 5

    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/ Unsatisfied/Very Unsatisfied)

  6. Localisation and annex fractures data collection

    Time frame: 12 months

    If applicable, localisation and annex fractures data collection, and the medical device's references used to treat thoses fractures.

Sponsors and collaborators

Lead sponsor

Global D

Industry

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2023
Registry last updated
Jul 7, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.