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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-07

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Trauma Injury Maxilla Fracture Maxillofacial Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Trauma surgery using Global D's implants.

Intervention Type DEVICE

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

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No