Study Evaluating the Performance and Safety of Global D Implants Indicated for Trauma Surgery (CMF-TRAUMA)

Recruiting

• Conditions: Maxillofacial Trauma; Maxilla Fracture; Trauma Injury
• Interventions: Device: Trauma surgery using Global D's implants.

• Registration Number: NCT05742932
• Lead Sponsor: Global D

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/MICROTEK®) used for trauma surgery.

Detailed Description

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

Investigators : at least 6 sites in France.

A statistical evaluation will be performed on those data in order to determine the performance and the security of those devices.

Study Timeline

• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-24
• Study Start: 2023-03-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Male or female patient, major or minor (11 years old minimum)
• Patient having first facial trauma surgery (maxillary, mandibular or maxillomandibular fractures with/without annex skull's or face's fractures)
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Trauma surgery using Global D's implants.	Male and female, major or minor patients. The patients have maxillary, mandibular, maxillomandibular fracture with/without annex face or skull fracture, and will be treated by trauma surgery.

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Performance of the Global D implants used for trauma surgery - Outcome Measure 1	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.
Security of the Global D implants used for trauma surgery - Outcome Measure 2	1 year	Adverse events identification, assessment and follow-up.
Security of the Global D implants used for trauma surgery - Outcome Measure 3	6 months	Bone consolidation after the surgery, 4-6 weeks after the surgery and 6 months after the surgery.
Surgeon satisfaction on the implant's utilisation - Outcome Measure 5	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)
Performance of the Global D implants used for trauma surgery - Outcome Measure 4	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).
Localisation and annex fractures data collection	12 months	If applicable, localisation and annex fractures data collection, and the medical device's references used to treat thoses fractures.

Trial Locations

Locations (2)

Hopital de la Croix Rousse - Hospices Civils de Lyon (FRANCE); 🇫🇷 Lyon, France

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