Maxilla Fracture, Maxillofacial Trauma, Trauma Injury
Conditions
Keywords
Performance, Safety, Screw, Plate, Medical device, Trauma surgery, Cranio-maxillofacial, 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 : 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.
Interventions
DEVICETrauma 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).
Sponsors
Global D
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJulie Chauvel-Picard, MD
Cranio-maxillofacial surgeon
Outcome results
None listed