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

Sponsor

Global D (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05742932

Collaborator

(none)

102

Enrollment

Location

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Injury Maxilla Fracture Maxillofacial Trauma	Device: Trauma surgery using Global D's implants.

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 Design

Study Type:

Observational

Anticipated Enrollment :

102 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Study to Evaluate the Performance (by the Assessment of Patient's Mandibular Function) and the Safety of Global D's Implants of Cranio-maxillofacial Surgery Indicated for Trauma Surgery (CMF-TRAUMA)

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Study group 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.	Device: Trauma surgery using Global D's implants. Major or minor participants who will be treated by an trauma surgery with ORTRAUTEK® or MINITEK/MICROTEK® implant(s).

Arm

Intervention/Treatment

Study group

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.

Device: Trauma surgery using Global D's implants.

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

Outcome Measures

Primary Outcome Measures

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

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.
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).
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)
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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