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)

N/AActive Not RecruitingNCT05742932

Global D102 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

102

Conditions

Trauma Injury Maxilla Fracture Maxillofacial Trauma

Interventions

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).

Eligibility

Sex: ALLMin age: 11 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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

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).

Time frame: 6 months

Secondary Outcomes

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

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.

Time frame: 6 months

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

Adverse events identification, assessment and follow-up.

Time frame: 1 year

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

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

Time frame: 6 months

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

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).

Time frame: 6 months

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

Data from ClinicalTrials.gov

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